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Bio Pharma Day
Dove Scienza e Lavoro
si incontrano

online from 16th October 2024
onsite in Rome on 29th 
October 2024


WHAT IS BIO PHARMA DAY?

Bio Pharma Day is an exclusive career event organized by Jobadvisor, entirely dedicated to job and training opportunities in the pharma and biotech industries.

Bio Pharma Day is aimed at students, graduates, and young professionals with backgrounds in biomedical sciences, biotechnology, chemistry, pharmacy, medicine and healthcare, and medical and biomedical engineering, from leading Italian universities.

In 2024, Bio Pharma Day will consist of two virtual fairs (in March and October) followed by two on-site events (in Milan and Rome).



Are you a Company willing to attend?
 
For more information or a quotation, please contact us: 
T: + 39 393 92.55.808  
E: biopharmaday@jobadvisor.it


NEXT LIVE STREAMING
Thursday 10 October - h. 6.00 p.m.

BIO ACADEMY: STEP #3 LinkedIn per la ricerca del lavoro!

WEBINAR


Here is the webinar's calendar.
You can attend the live streaming session or watch the video recordings.
 
Stay Tuned: more webinars will be added soon! 

COMPANIES

These are the companies that you can meet at Bio Pharma Day:
Discover their profiles.

GREEN label: VIRTUAL Job Fair from 16th October
YELLOW label: ROME on 29th October at Centro Congressi Cavour

More companies will be added soon!

OPPORTUNITIES

Here you will find the list of opportunities at Bio Pharma Day.

More Opportunities will be added soon!

If you are logged in, the first ones marked with    or   are close to your degree or field of studies. 

Application will be open from 16th October until the end of the Virtual Job Fair!

Company
Title

Junior Automation Engineers Pipeline
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Employer: Novo Nordisk - Denmark

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Locations: We are looking for candidates to all our locations. This specific pipeline covers on-site positions in Greater Copenhagen area e.g.: Bagsværd, Gentofte, Søborg, Lyngby, Måløv, Kirke Værløse.

The Role & Department
Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Are you driven by automation and digitalization of the Novo Nordisk manufacturing value chain? Look no further!

Joining the Automation Engineers Pipeline

By applying for the pipeline, you will be considered as a potential match for on-site automation related positions, which align with your background, skills, and interests across various areas in Denmark.

Due to the expansion of our activities in all business areas and sites, we are currently seeking talents for many different teams across Novo Nordisk, such as Advanced automation, Manufacturing Execution Systems (MES), and Collaborative- and industrial robotics. We encourage you to read more detailed information about the different roles and areas through this link: https://www.novonordisk.com/careers/campaigns/automation-engineer-process-digitalization.html

Requirements
We are looking for someone with an innovative and solution-oriented mindset. As you will be working and collaborating with people from various departments in the organization, it would be preferable that you are ready to take the lead on deploying solutions that bring value.

To apply to our pipeline, we expect that you:

  • Are newly graduated with a bachelor’s or master’s degree within e.g., IT, Automation, or Robotics
  • Would like to build on your skills and experience together with highly dedicated colleagues.
  • Are proactive, solution-oriented, like to share your knowledge and collaborate effectively.
  • Work systematically and with the ability to develop and implement practical actions to deal with issues.
  • Have proficient oral and written communications skills in English. Danish language skills are great advantage.
  • As documentation according to Good Manufacturing Practice (GMP), rules are part of our daily work, it is important that you thrive in ensuring that all your work is well documented.

 

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Newly graduated Automation Engineer at Novo Nordisk Engineering
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Employer: Novo Nordisk Engineering (NNE)

Does the idea of learning about Process Control Systems excite you? And do you thrive in gaining knowledge of GMP and pharmaceutical production? Then you’ll fit right in!

We are experts in end-to-end pharma engineering, and we design and build pharma facilities that are essential for millions of patients all over the world. Our success is built on our relationships, both with our colleagues and our customers. If you are passionate about working for a noble cause on projects shaping the future of sustainable and intelligent pharma facilities, NNE is the place to be. 

Locations: Kalundborg

The Role & Department
We are looking for newly graduated Automation Engineers to join our team of Process Automation Engineers. As a team, we are working on the biggest projects in Novo Nordisk history. Our goal is to implement robust and future-proof solutions for our customers. Your role will be key in designing, implementing, and validating automation solutions for the pharmaceutical industries.

Responsabilities

  • Designing, developing, implementing, qualifying, and supporting Process Control Systems /Distributed control system (DCS).
  • Interacting with process experts and colleagues with expertise in surrounding systems and equipment like Manufacturing Execution System (MES), Historian systems, Instruments, Production equipment etc.
  • Developing and optimizing automation methods and strategies to meet our customers’ challenges and sharing state-of-the-art knowledge with colleagues and partners.
  • Advising customers on their selection of automation solutions.
  • Forming the basis of automation strategies and architectures to support our sister departments internationally and expand NNE’s Process Automation engagement.

Requirements
We care about who you are as a person. In the end, how you work, and your energy, is what impacts the results we achieve as a team.

As a person, you are:

  • A team-oriented person, curious and eager to learn.
  • Comfortable with customer relations.
  • Passionate about your work and with a personal drive.
  • Pro-active, cooperative and with a motivated mindset.

We believe these qualifications are needed for you to do well in this role:

  • You have a degree within chemistry, automation, or electrical engineering.
  • You have an interest of working with PCS/DCS Application development such as ABB 800xA or ABB SattLine).
  • You find the GMP/GAMP environment exciting.

If you do not check all the boxes, you are welcome to offer alternative experience that you think would be valuable in this role.

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Informatore Scientifico del Farmaco
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AURORA BIOFARMA, importante azienda farmaceutica in forte espansione a livello nazionale ed internazionale con sede a Milano, titolare di farmaci in fascia A, dispositivi medici e integratori alimentari sta ricercando, per il potenziamento della propria rete, Informatori Scientifici del Farmaco su tutto il territorio italiano.

Ruolo: Informatore Scientifico del Farmaco

Sede: su tutta Italia
Contratto:
contratto autonomo a Partita IVA in monomandato.

I candidati ideali sono:

  • Laureati in discipline scientifiche con titolo di studio idoneo (Dlgs 219/2006) o titolo equipollente o esperienza pregressa.
  • Orientati al lavoro per obiettivi e disponibili a lavorare sul territorio assegnato.

Competenze e capacità richieste:

  • Motivazione, proattività e orientamento al raggiungimento dei risultati.
  • Saper costruire relazioni professionali di valore e interpersonali.
  • Capacità organizzativa e autonomia.
  • Solide conoscenze scientifiche di base.
  • Utilizzo dei dispositivi elettronici come PC e tablet, sistemi informatici e database aziendale.
  • Patente di guida B ed automuniti.

Offerta aziendale:

  • Materiale promozionale e supporto formativo continuo in sede e sul campo.
  • Provvigioni tra le più elevate del settore ed incentivi.
  • Concrete opportunità di crescita professionale.
  • Politiche commerciali stimolanti e meritocratiche.
  • Auto aziendale su richiesta

Nella cover letter specificare per quale area geografica ci si candida.

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Scientist, QA Manufacturing Support
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Employer: AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.  

The Role & Department
The QA Manufacturing Support Scientist is responsible for quality activities supporting Manufacturing Operations in accordance with procedures and GMP requirements. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.

Location: Copenhagen, Denmark

Responsibilities

  • Provide an “on-line” Quality presence in the production area during manufacture regarding on the line documents and product checks and quality support for production enquiries. To inform line management of any issues relating to the quality of products or materials.
  • Perform QA sign off after set-up to confirm that the manufacturing line has been set up as per requirements in batch documentation and associated SOPs.
  • Conduct batch record “Stage Approval” as part of batch release process.
  • Participate in Gemba walks of the production area and conduct specific site systems audits in accordance with the agreed schedule.
  • Shipping/ prepacking approval.
  • Manufacturing label management. 
  • Archiving.
  • Review and approval of validation/ qualification documentation.
  • Review all batch documentation, liaising with production management to resolve and clarify any points of issue.
  • Work with manufacturing to drive improvements in GMP compliance across all shifts.
  • Support manufacturing during batch review with Good Documentation Practice related queries.
  • Perform Quality review and approval of deviations (DEVs), change controls (CRs) and CAPAs.
  • Buffer and media MPR review and approval

Requirements  

  • Bachelor's and/or Master’s degree in Natural Sciences.
  • Alternatively, certified laboratory technician with a degree in laboratory science, biotechnology, medical laboratory technology including 3-5 years experience within a GMP environment in the Pharma Industry.
  • Experience with BPR/MPR review will be a plus.
  • Previous biopharma experience is preferred but not a requirement.
  • Strong working knowledge of the principles and guidelines for GMP is a plus.
  • Strong decision maker and ‘can do’ attitude. 
  • Excellent written and verbal communication skills to internal and external stakeholders.
  • Ability to work in a fast paced, matrix environment is essential.
  • Capable of working to deadlines and prioritizing multiple tasks.
  • Flexibility to meet changing needs and priorities of the business.
  • Experience working in a GMP aseptic manufacturing environment will be a plus.  

 

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Researcher in ex vivo dietary microbiome interventions
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Employer: Copenhagen University

Place of employment
Novo Nordisk Foundation Center for Basic Metabolic Research (CBMR) is an academic research Center that pioneers groundbreaking research towards better cardiometabolic health. Through collaborative interdisciplinary research from single-cell genomics to whole-body systems, CBMR aims to transform the basic understanding of cardiometabolic health and accelerate its translation into prevention and treatment strategies. The Center’s uniquely multi- and interdisciplinary approach combines research in genetics, physiology and pharma­cology, to better understand the complex interplay of the many factors that drive cardiometabolic disease. 

The Role, Project & Departement
We are looking for an experienced and motivated Researcher having extensive experience with ex vivo and in vitro microbiome culture and characterization to work in the Arumugam Group at The Novo Nordisk Foundation Center for Basic Metabolic Research (CBMR). The position is a 2-year position starting December 1, 2024, or after agreement.

The project aims to decipher how dietary components affect specific members of the human gut microbiome using high-throughput dietary interventions on ex-vivo human gut microbiomes.

The Microbiome Systems Biology research group led by Associate Professor Manimozhiyan Arumugam investigates how health and diseases are influenced by our gut microbiome, how the gut microbiome interacts with the host and environmental factors, and how we can therapeutically modulate the gut microbiome to improve metabolic health. The group takes an interdisciplinary approach combining multi-omics microbiome data to study host-microbial cross-talk.

Responsabilities
Your tasks will include:

  • In-vitro culturing and characterizing complex microbial communities; designing and performing dietary/nutrient intervention on these communities; and performing molecular microbiology characterizations.
  • You will work closely together with lab technicians, bioinformaticians and researchers at multiple levels.
  • We expect you to operate and run fed-batch anaerobic fermenters, perform sample collections and extraction of nucleic acids and metabolites.
  • You will be responsible for coordinating the running of multi-omics (metagenomics, metatranscriptomics, meta-proteomics and metabolomics) and data analysis with technicians and bionformaticians.
  • You will also participate in collaborative projects with other research groups at the Center that involves in vitro culturing of gut microbiota.
  • Lastly, you will be expected to actively contribute to creating novel ideas, writing research publications and grant applications, supervising students, and presenting the results at seminars and conferences.

Requirements
We are looking for a highly motivated and enthusiastic Researcher with the following competencies and qualifications:

Essential criteria:

  • PhD in microbiology, molecular biology or a similar field
  • Minimum of three years’ of postdoc experience.
  • Strong project management and coordination skills.
  • Solid experience in operating large volume anaerobic chambers.
  • Solid experience in operating fed-batch fermenters (e.g. SHIME, TIM-2) and maintaining continuous cultures of fecal microbial communities.
  • Strong experience in generating and interpreting metabolomic data from in vitro microbial communities.
  • Strong collaborative skills; ability to share knowledge and expertise, and provide support to a multidisciplinary team.
  • Proven track record showing scientific productivity in peer reviewed journals.
  • Excellent written and oral communication skills in English.
  • Strong interest in learning more about the life science area, particularly metabolic disorders.

Desirable criteria:

  • Experience in culturomics approaches.
  • Experience in setting up defined synthetic microbial communities in vitro.
  • Experience in identifying high-value compounds from microbial world.
  • Insight in the area of health, life science and nutrition research.

Terms of employment
The employment as Researcher is a full time and fixed-term position for 2 years. Starting date is December 1, 2024, or after agreement.
Salary, pension and terms of employment will be in accordance with the agreement between the Ministry of Taxation and AC (Danish Confederation of Professional Associations). Depending on qualifications, a supplement may be negotiated.

Non-Danish and Danish applicants may be eligible for tax reductions, if they hold a PhD degree and have not lived in Denmark the last 10 years.
The position is covered by the “Memorandum on Job Structure for Academic Staff at the Universities” of June 28, 2013.

Further information
For further information please contact Associate Professor Mani Arumugam at 
arumugam@sund.ku.dk. For questions regarding the recruitment procedure, please contact SUND HR CBMR at SUND-HR-CBMR@sund.ku.dk

 

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Informatori Scientifici - varie sedi Italia
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Il nostro cliente è un’azienda italiana leader nel settore degli integratori alimentari, dei dispositivi medici e dei farmaci, impegnata nel migliorare la salute e il benessere delle persone attraverso prodotti di alta qualità.

Ricerchiamo un/a INFORMATORE/TRICE SCIENTIFICO DEL FARMACO

Inizio previsto: gennaio 2025
Contratto: Assunzione diretta da dipendente secondo il CCNL Commercio, inquadramento e durata contrattuale variano sulla base dell’esperienza del candidato.
Completano l’offerta economica: Bonus variabile al raggiungimento dei KPI concordati, benefits (auto aziendale ad uso promiscuo).

La posizione offre l'opportunità di rappresentare e promuovere i prodotti dell’azienda presso medici di medicina generale, farmacisti e medici specialisti in area: ginecologia, gastroenterologia, oncologia e nutrizione.

Responsabilità:

  • Presentare in modo efficace i prodotti ai professionisti sanitari.
  • Fornire informazioni scientifiche accurate e aggiornate sui nostri prodotti.
  • Collaborare al raggiungimento degli obiettivi di vendita.
  • Partecipare a conferenze ed eventi per promuovere la conoscenza dei prodotti.
  • Monitorare e riportare le tendenze di mercato e le attività della concorrenza.

Requisiti:

  • Laurea scientifica in base al DL 219/2006 e successivi.
  • Esperienza precedente come Informatore Scientifico del Farmaco.
  • Eccellenti capacità di comunicazione e presentazione.
  • Conoscenza approfondita del settore farmaceutico, dei dispositivi medici e degli integratori alimentari.
  • Orientamento ai risultati e capacità di lavorare in team.

Zone lavoro:

  • Monza Brianza
  • Piacenza
  • Parma
  • Reggio Calabria
  • Messina
  • Sassari

Nella cover letter specificare l'area geografica di interesse.

 

 

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PhD Scholarships in Piezoelectric Biopolymer Technology and Devices for Drug Delivery on Demand – DTU Health Tech
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Employer: Technical University of Denmark

If you are establishing your career as a scientist and you have the ambition to develop groundbreaking smart technologies and devices for healthcare, this is the right research project for you.

The aim of the PhD project is to explore and develop new piezoelectric biomaterials and technologies for controlled drug release in smart devices by the application of ultrasound. The focus of the activity will be i) to produce thin films of biomaterials with high piezoelectric properties and loaded with drug molecules, ii) to develop MEMS devices based on piezopolymers, and iii) to develop and optimize a strategy for the remote release of drugs on demand. Within the framework of IDUN, we have extensively explored engineered micro-encapsulated pharmaceutical compounds and more advanced oral drug delivery concepts. In addition, we have expertise on developing piezoelectric materials and device fabrication methods for sensors and actuators for the human body. The PhD candidate will be a part of the IDUN center of excellence, led by Prof. Anja Boisen at DTU Department of Health Technology, and will work under the supervision of Prof. Massimo De Vittorio. IDUN is a highly cross-disciplinary research center with over 40 members, that focuses on development of micro and nanotechnology-based sensors, detection systems and drug delivery devices.

Responsibilities
Your overall focus will be on the design, realization, and test of devices such as smart pills or flexible MEMS transducers based on piezoelectric biopolymers such as chitosan and cellulose, the two most abundant biopolymers on earth. You will work with nearby colleagues and with academic, clinical, and industrial partners in Denmark as well as abroad. 

Your primary tasks will be to:

  • Develop biopolymers thin films embedding drugs with high piezoelectric properties.
  • Tailoring the optical, mechanical, piezoelectric and electrical properties of the thin films by advanced and innovative fabrication methods for improving retention and drug delivery on demand. 
  • Design and fabricate piezoelectric devices by advanced micro and nanofabrication methods.
  • Employ ultrasound in order to trigger and speed up the drug release from the piezoelectric biopolymers. Tests will be executed first in vitro and then, after successful validation, in vivo.
  • Teach and supervise BSc and MSc student projects, and be co-supervisor for PhD students

The research activity will be carried out within the framework of the Center of Excellence – IDUN. In IDUN, our motto is ‘bringing science to life’ and we believe in openness, inclusiveness, having ambitions, making a difference and collaboration.

You will play a role mainly in the “Optomechanical Biointerfaces” research group coordinated by prof. Massimo De Vittorio of the IDUN section, and you will interact with several members of IDUN working in different disciplines, such as biology, microfabrication, pharmaceutical science and polymer science. The project is highly interdisciplinary, and we expect that you enjoy teamwork.

Requirements

  • You have a background in materials science, chemistry and/or microfabrication technologies.
  • You are highly independent, self-motivated and enjoy collaboration in a multidisciplinary academic environment.
  • You have the ability to drive the project forward, supervise students and achieve ambitious goals.
  • You must have a two-year master's degree (120 ECTS points) or a similar degree with an academic level equivalent to a two-year master's degree. 

We offer
DTU is a leading technical university globally recognized for the excellence of its research, education, innovation and scientific advice. We offer a rewarding and challenging job in an international environment. We strive for academic excellence in an environment characterized by collegial respect and academic freedom tempered by responsibility.

Terms of employment
The appointment will be based on the collective agreement with the Danish Confederation of Professional Associations. The allowance will be agreed upon with the relevant union. 
The period of employment is 3 years. The expected start date is 1 January 2025 or shortly thereafter.

Further information 
Further information may be obtained from Professor Massimo De Vittorio, 
mdevit@dtu.dk 



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Medical Manager
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Reporting to: Medical Affairs Director
Location: Florence, HQ


CONTEXT
The Medical Affair Team (Italy) has the primary objective to support he scientific information and development on the Menarini products.
The Medical Manager works closely with the Product Manager. Other internal relationships include relations with MSL Lead, Pharmacovigilance and Regulatory personnel. External relationships include MSLs, Medical Reps, Corporate Medical Managers, Scientific Societies,KOLs

MAIN ACTIVITIES AND RESPONSIBILITIES

  • Cooperate with Product Manager in developing of the medical component of the brand strategy;
  • Develop and execute medical affairs plan for the products;
  • Manage clinical trials in cooperation with Corporate Medical Affairs department, in the role of LOCAL Study Medical Expert;
  • Develop a proper advocacy plan and engage with national Key Opinion Leader;
  • Support MSLs in the execution of the local medical plan;
  • Release scientific trainings to medical reps and MSLs;
  • Create and review promotional materials;
  • Cooperate with other Departments (Regulatory/Market Access/Pharmacovigilance) in the preparation of relevant documents necessary to meet the requirements of local Health Authorities;
  • Medical enquiries management;
  • Support/investigate life cycle management initiatives for the products.

JOB REQUIREMENTS

  • Bachelor's degree in Medicine;
  • Specialization in internistic disciplines or pharmacology preferred;
  • Fluent English in written and verbal format;
  • Optimal use of Microsoft Office (PowerPoint, Excel and Word);
  • Communication and public speaking skills;
  • Relational and organizational skills;
  • Team working skills;
  • Up to 30% overnight travel, including abroad required.
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Vestas Global Graduate Programme
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Employer: Vestas

The Vestas Global Graduate Programme is an important part of our talent strategy. Through the programme, we aim to seek out the future people- and business leaders, specialists, and project managers that can help us reach our ambitious objectives – and make the world a better place while doing so.

The programme is the ideal opportunity for you to embark on an exciting global career while contributing to the solution of one of the most urgent challenges of our time: the climate crisis.

Do you want to play a pivotal part in the green energy transition?

The four areas of interest:

  1. Business, Commercial & Strategy
  2. Digital, IT & Projects
  3. Supply Chain, Service & Logistics
  4. Engineering, R&D & Innovation

How it works?
As a global programme, the Vestas Global Graduate Programme provides you with the opportunity to work in two different areas and locations of our organisation, allowing you to gain a thorough understanding of our purpose, values, and culture. Throughout the two years, you will get two rotations of 12 months each, starting in September. You will be exposed to five modules, each with a different leadership focus. As a Graduate, you will hold a full-time position where you will be equipped with the tools, support, and knowledge you need to succeed. The salary offered is comparable to an entry level position depending on the country in which you are hired.

When does the Graduate Program start?
The recruitment window for the 2025 Vestas Global Graduate Programme will open 1st of December 2024 and close on the 15th of January 2025 at 23.59 CET.

For foreign students:
In order to qualify for the Vestas Global Graduate Programme, you must already have completed either your Bachelor’s or Master’s degree and possess a valid work permit in the country that you are applying for. 

Further information: 
https://www.vestas.com/en/careers/early-careers/graduate-programme

⚠️ To submit your application, please go to the following site:
https://www.vestas.com/en/careers/early-careers/graduate-programme

-

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QA & Packaging Cosmetico (Internship)
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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partnership con una tra le migliori aziende cosmetiche italiane del make-up e skincare, eccellenza del made in Italy, offriamo un'interessante e stimolante opportunità:

Internship in qualità e packaging cosmetico

Sede: provincia di Bergamo

Contratto: stage di 6 mesi, retribuzione 800 euro al mese, mensa, scopo assunzione. In caso di esperienza pregressa, si valuta inserimento in apprendistato.
Orario di lavoro:
8:00-16:30 con flessibilità fino a 9:15-17:45

Responsabilità:

  • Analisi e procedure finalizzate a garantire la compatibilità con il packaging.
  • stendere report su rapporti di compatibilità.
  • fornire informazioni al marketing.
  • omologazione del packaging.
  • corretta compilazione della documentazione.

Requisiti richiesti:

  • Laurea in ambito scientifico.
  • Preferibile esperienza pregressa (anche stage).
  • Buona conoscenza della lingua inglese.
  • Passione per la cosmesi. 
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Regulatory Affairs – Promo & Congresses (Internship)
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

  • Manage promotional materials: ensure that all promotional contents and initiatives for pharmaceutical products complies with regulatory requirements and industry standards, overseeing the approval process before materials are used in marketing campaigns.
  • Collaborate with cross-functional teams: work closely with marketing, medical, and legal teams to align promotional strategies with regulatory guidelines, ensuring that messaging is accurate, compliant, up-to date and sufficiently complete.
  • Liaise with regulatory authorities: be responsible for submitting promotional materials to regulatory bodies for review, addressing any feedback or required modifications to ensure timely approval and market readiness.

What are the requirements?

  • Master's degree in Pharmaceutical Chemistry and TechnologyPharmacy or similar.
  • Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
  • Ability to work in a team and aptitude for learning.

What we offer?

  • Dynamic and challenging work environment with international projects.
  • Ongoing training and opportunities for professional growth. 
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Scientist, Manufacturing
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Employer: AGC Biologics

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

At AGC Biologics, you will get a unique opportunity working with a variety of different state of the art technologies among +40 different nationalities. This opens many doors for personal development and for you to make a real difference towards both patients, customers and own development. AGC offers an informal and friendly working environment, characterized by the fact that we think it is fun to go to work. We respect each other and our differences. AGC employees are flexible and take pride in working together to achieve goals - as one team.  

Location: Copenhagen, Denmark

The Role & Department
Do you have experience working in a cGMP environment and are you looking for new opportunities for further growth? Then this position could be something for you.  

As a CDMO, AGC Biologics manufactures drugs for a variety of different customers. Depending on the customer needs, this can be for drugs ranging from development, to clinical and commercial production. Right now, you have the opportunity to join the Mammalian department as a Review and compliance Supporter in Mammalian Production Coordination Team. This position requires high level process and compliance understanding as well as inter-departmental collaboration.  

The Mammalian Production coordination team owns the production process of all products. This includes to support the Production with an error-free and timely production execution and own batch documentation, review and deviation handling. The team has in depth knowledge of the product specific requirements. 

Responsabilities  

  • Responsible for/Consulted during MPR creation on process steps to align production flow and GDocP requirements.
  • Daily review of documentation in production.
  • Accountable for timely batch review according to KPI.
  • Accountable for timely deviation closure (incl. systematic problem-solving during root cause investigation) according to KPI.
  • Responsible for enabling timely batch release.
  • Responsible for data feedback/status on release process. 

Other 

  • Responsible for capturing learnings and align with MPR template owner to continuously improve MPR template.
  • Responsible for sharing knowledge across project groups. 

Requirements  
The ideal candidate holds an Academic degree within science and have previously been working in a manufacturing team operating under cGMP preferably within the pharmaceutical industry. The ideal candidate for the position has several of the below competencies/experiences: 

  • Experience in preferably in commercial/commercial GMP manufacturing. 
  • Have experience with and demonstrated understanding of Good Manufacturing Practices (GMP).
  • Have experience writing, reviewing and approving GMP documentation. 
  • Experienced with operations of single-use technologies and aseptic processing. 
  • Self-motivated, organized and proactive. 
  • Ability to coordinate multi-departmental tasks and deliverables (interaction with Process Transfer, Process Development, Engineering, QA, QC, etc.). 
  • Experience working with multiple projects simultaneously. 
  • Demonstrated experience leading troubleshooting efforts. 
  • Strong communication skills necessary to interact with internal and external stakeholders. 
  • Strong presentation skills.   

 

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Corso "Missione CRA"
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Il corso in breve
Il corso Missione CRA è un corso online formulato per chi desidera diventare professionista nel settore della ricerca clinica. Cinquanta ore di formazione e contenuti extra per conoscere questa realtà professionale e scoprire quali sono le mansioni del Clinical Research Associate e degli altri attori coinvolti. Trainer esperti, che lavorano ogni giorno della ricerca, condividono la propria esperienza attraverso attività pratiche, project work e confronto diretto durante le lezioni live. Ogni lezione è online e viene registrata affinché si possa rivedere e recuperare sulla piattaforma e-learning.

Al termine del percorso formativo:

  • avrai compreso i principi delle Good Clinical Practice (GCP);
  • avrai colto i meccanismi che governano lo sviluppo di un nuovo farmaco in un contesto regolato da normative italiane e regolamenti europei;
  • saprai cosa è la Farmacovigilanza e come si gestiscono gli eventi avversi;
  • sarai consapevole di quelle che sono le principali sfide e le grandi opportunità del mondo della Ricerca Clinica;
  • avrai completato le ore formative richieste dal DM 15/11/2011.

Oltre ad una formazione specifica sulla ricerca clinica, durante il corso Missione CRA viene fornita assistenza e supporto nella ricerca attiva del lavoro, attraverso la revisione dei curricula, lezioni di coaching e accesso ad un canale riservato con i diversi annunci di lavoro.

Prossima edizione
La prossima edizione avrà inizio il 15 maggio e terminerà il 21 luglio.

Modalità di partecipazione
Il corso non richiede specifici requisiti di accesso, solo il desiderio di conoscere la realtà della ricerca clinica. La frequenza alle lezioni live non è obbligatoria ma altamente consigliata per poter interagire con i trainer e svolgere al meglio le attività pratiche. Anche chi non partecipa alle live può in ogni caso seguire il corso tramite le registrazioni e ottenere il certificato superando l’esame finale.

Contatti
email: info@missionecra.com
cell/whatsapp: +39 3791292555
sito: www.missionecra.com

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Commissioning & Qualification Intern
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Ruolo: Commissioning & Qualification Intern

Sede: Latina
Contratto: iniziale stage extracurriculare trimestrale, finalizzato ad assunzione in apprendistato.

Disponibilità: Immediata

S4BT è un’Azienda di oltre 80 specialisti e specialiste, che da oltre 25 anni fornisce Soluzioni Software e consulenze per il settore Life Science e non solo in ambito Quality Assurance, Engineering, Project Management, Validazioni, Tech Transfer, Convalide e altro.

A supporto della crescita aziendale, ricerchiamo giovani neolaureati/e che, affiancati/e ad un tutor, intraprenderanno un percorso formativo che li porterà a ricoprire il ruolo di Commissioning & Qualification Intern all’interno del gruppo Quality & Operation.

Cosa ci piace in un/a candidato/a?

  • L’approccio da vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro.
  • La curiosità, l’entusiasmo e l’energia.
  • La ricezione di fronte alle linee guida aziendali.
  • La partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Cosa richiediamo?

  • Laurea in materie tecnico-ingegneristiche (es. Ingegneria Chimica, Chimica, Chimica Industriale, Chimica e Tecnologie Farmaceutiche, Biotecnologie, Ingegneria Meccanica, Ingegneria dei Sistemi e dell’Automazione).
  • Buona conoscenza della lingua Inglese sia scritta che parlata.
  • Buona conoscenza del pacchetto Office.
  • Interesse e curiosità nelle qualifiche di equipment, ambienti ed utilities, dedicati alla produzione chimico-farmaceutica.
  • Interesse e curiosità in ambito Quality Assurance and Compliance.

Cosa imparerai?

  • Avrai l’opportunità di intraprendere un percorso formativo su attività di progetto di Commissioning & Qualification, all’interno del gruppo Quality and Operation.
  • Offrirai supporto alle attività di Commissioning & Qualification, Quality Assurance and Compliance.

Si offre: sistema di welfare, previdenza complementare aziendale, benefit, formazione continua, eventi. 

Se ti interessa la posizione vieni a conoscerci a Roma, il 29 ottobre 2024, oppure contattaci su LinkedIn!

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Quality Assurance Internship
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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it)la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partership con una tra le migliori aziende cosmetiche italiane del make-up e skincare, eccellenza del made in Italy, offriamo un'interessante opportunità in ambito:

ASSICURAZIONE QUALITA'

Sede di lavoro: provincia di Bergamo

Contratto: stage di 6 mesi, retribuzione 800 euro al mese, mensa, scopo assunzione.
Orario di lavoro: 8:00-16:30 con flessibilità fino a 9:15-17:45

Requisiti:

  • Laurea in ambito scientifico.
  • Conoscenza lingua inglese livello B2.
  • Passione per la cosmesi.
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Technicians / Service Engineers – DTU Nanolab
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Employer: Technical University of Denmark

At DTU Nanolab, we are expanding our activities within micro- and nanofabrication and therefore need more technicians/service engineers to join us in the development of the technical solutions of tomorrow. DTU Nanolab is one of the world’s best-equipped open access centers within nanofabrication and characterization located at the Technical University of Denmark in Copenhagen. We are seeking curious and dedicated candidates to join our technical support teams in up to four new positions. We encourage both experienced technicians as well as newly educated candidates with a background from vacuum, refrigeration or mechatronics systems to apply.

Our cleanroom facility houses more than 150 highly advanced tools. The tools combine many different areas such as high vacuum technology, RF plasma, gas-handling systems (toxic and non-toxic), pneumatic control systems, and heating/refrigeration systems. This means that you should be able to navigate and troubleshoot in systems with high complexity.

Responsabilities
You will become a member of one of our equipment groups that consist of process specialists and equipment engineers. Here, you will be working together with extremely competent specialized colleagues with a focus on repair and maintenance to ensure that the equipment can meet our quality standards. We expect you to strive to deliver high quality, safe and reliable solutions.

Key tasks include:

  • Take part in the equipment maintenance 
  • Troubleshooting/repair of equipment breakdowns
  • Participate in organizing maintenance and repair tasks
  • Keep focus on safe working environment
  • Maintaining spare parts inventory
  • Carrying out machine upgrades 
  • Documenting breakdowns, repairs and maintenance tasks

Requirements
For these positions, you should have:

  • A minimum of 3 years relevant education within automation, mechatronics or electronics or related technical field relevant work experience may compensate for lack of formal education.
  • Experience of working with vacuum systems, pneumatic controls, electronics, and gas systems would definitely be of benefit but not essential as we are prepared to train the successful candidates.
  • You should be safety minded, self-driven, and pro-active. Since you will be working as part of a team, it is important to have a positive and open-minded attitude.

What we offer
We offer an interesting and challenging job in an international atmosphere with the focus on research, teaching, innovation, and scientific advice for the benefit of the surrounding community. We have an informal and welcoming work atmosphere where commitment is essential, and we keep up a good spirit. Our approach to planning and conducting tasks is team oriented with focus on a well develop social work environment. We offer great flexibility in the position and expect similar flexibility from you.

Terms of employment
Salary and appointment terms are in accordance with either the collective agreement with the Danish Confederation of Professional Associations (AC), or the OAO-S Joint Agreement and the organization agreement for Laboratory Technicians and IT staff (HK/Stat), for Craftsmen and Technicians, for Engineering Assistants and Research Technicians at research institutions, etc., or other relevant agreement.

The position is permanent and full-time (37 hours per week). Starting date as soon as possible (according to mutual agreement). 

The workplace is DTU Lyngby Campus.

Further information
If you would like additional information about the position, please contact Head of Process Engineering Flemming Jensen, 
flje@dtu.dk

 

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Laboratory Manager for reNEW
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Employer: Copenhagen University

Place of employment
The Novo Nordisk Foundation Center for Stem Cell Medicine, reNEW is a worldwide consortium with nodes at the University of Copenhagen, Murdoch Children’s Research Institute, Melbourne, Australia and Leiden University Medical Centre, Netherlands. Researchers within reNEW addresses fundamental questions in stem cell biology and translate research findings to products that will help patients with incurable disorders such as congenital kidney disorders, diabetes, heart defects, neurological conditions, chronic ulcerative conditions, respiratory diseases, bladder defects and infertility.

reNEW Copenhagen is a vibrant, internationally diverse, and ambitious research center with state-of-the-art facilities located at the Faculty of Health and Medical Sciences, University of Copenhagen. The setting is ideally suited for seamless collaboration and access to a large variety of technology platforms within the Copenhagen area as well as within the other reNEW units in Melbourne and Leiden.

The Role
The role of the laboratory manager is to support and enable researchers to perform their work safely and efficiently while ensuring smooth operations within the reNEW laboratories.
The laboratory manager will report directly to the center management and head of staff.

Responsabilities
The tasks include:

  • Ensuring optimal usage of instruments and laboratories.
  • Ensuring that the laboratories are following all legal requirements.
  • Communication and training of health and safety rules.
  • Arranging procurement and services of common equipment.
  • Supporting purchase of common laboratory items, including through contact with suppliers, and general organization of stocks, shipment reception and distribution within reNEW.
  • Managing the lab operations team, including task and work assignment
  • Collaboration and communication with the laboratory users.
  • Collaborate and coordinate with reNEW Technology Platform leads to ensure continuous and smooth daily operations.
  • Organisation of laboratory users group meetings.
  • Taking part in various meeting within the university (Chemical coordinator, lab manager, etc.).
  • Budgeting and reporting of common laboratory expenses and handling of internal cost recovery where applicable.
  • Reacting to matters raised by laboratory colleagues and providing guidance and support to address suggestions and incidents.

Requirements

  • You have as a minimum a laboratory or university-based education within the field of life sciences, natural sciences or similar.
  • You have experience in laboratory management (minimum of two to three years) and people management.
  • You have experience in GMO1 laboratory settings, including tissues culture.
  • Experience in Kemibrug, GMO2 laboratory, Sharepoint, booking systems, and/or Lab Guru is desirable.
  • Experience and training in health and safety rules and regulations is desirable.
  • Very good communication skills in Danish and English (written and verbally).
  • You are a friendly and open, yet firm and effective communicator across the broad spectrum of scientific employees within an internationally staffed institution.
  • You have an efficient and self-organised working style and experience of how to effectively communicate in a multifaceted organisation and smaller task-oriented teams.
  • You commit to being physically present and readily available in the lab during working hours.

We offer

  • A stimulating, challenging and multifaceted research environment
  • A combination of active scientific service platforms to interact with, and to develop ideas together to improve our lab for everyone
  • Involvement in cutting-edge research in a diverse and multicultural community
  • Possibility for continued education and training
  • Attractive employment conditions
  • Centrally located workplace.

Terms of employment
Your employment will be at Novo Nordisk Foundation Center for Stem Cell Medicine, University of Copenhagen. The position is full-time (37 hours per week) and for 2 years, and it is open for appointment on 15th of November 2024 or as soon as possible.

Employment as Biomedical Laboratory Scientist will be in accordance with the agreement between the Danish Ministry of Finance and Danske Bioanalytikere
Employment as laboratory technician will be in accordance with the agreement between the Danish Ministry of Finance and OAO/HK STAT. The position is placed in salary group 5.

Depending on qualifications a supplement may be negotiated.

Further information
For further information please contact Associate Professor, Mariaceleste Aragona;
mariaceleste.aragona@sund.ku.dk

 

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Regulatory Affairs Specialist – Procedures
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

  • Prepare the strategy, the technical documentation, perform the submission (through national and EU portals) and follow-up until approval of MRP, DCP, CP and National Procedures for new marketing authorizations, variations, marketing authorization transfers and renewals according to the relevant EU Regulation and national requirements.
  • Give support for the electronic submission (eCTD) and preparation of checklists and e-submission ready documents for different regulatory activities.
  • Manages the regulatory procedures in coordination with the Client’s team and the contact with Regulatory Authorities together with or on behalf of the client.

What are the requirements?

  • Degree in Pharmaceutical Chemistry and TechnologyPharmacy or similar.
  • At least 1 year of experience in similar roles.
  • Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
  • Ability to work in a team and aptitude for learning.

What we offer?

  • Dynamic and challenging work environment with international projects.
  • Ongoing training and opportunities for professional growth.

 

 

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Master Quality: Esperti e Manager in Sistemi di Gestione Aziendale - 87' edizione
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Sei un biologo, un chimico o hai una laurea in CTF?
Vuoi fare la differenza nel settore farmaceutico, alimentare o in altri ambiti strategici?

Il Master Quality di Uninform Group – giunto alla 87ª Edizione – ti offre una formazione completa e approfondita nei sistemi di gestione aziendale, con focus su qualità, ambiente, sicurezza e agroalimentare, permettendoti di acquisire competenze e titoli altamente richiesti dal mercato del lavoro e di contribuire all'innovazione e alla sostenibilità delle aziende.

Iscriviti ora e diventa un professionista del futuro!

Date, modalità di frequenza e numeri del Master:
La prossima Edizione inizierà il 23/10/2024, l’Edizione successiva inizierà a febbraio 2025 (ogni anno si prevedono 3 Edizioni a febbraio, maggio, ottobre).

Il Master Quality si svolgerà con frequenza full time, dal lunedì al venerdì dalle 09:00 alle 18:00, in modalità E-Learning oppure a Roma o Milano.

-2 mesi di fase d’aula con un piano di Studi completo e trasversale e con docenti professionisti del settore.
-6 mesi di stage garantito presso una delle oltre 750 aziende partner, tra le più importanti in tutti i settori dell’economia, ed in particolare in ambiti alimentare, farmaceutico, biomedico, consulenziale, aerospaziale, e molti altri.
-15 Attestati qualificati CEPAS, compresi i Lead Auditor in Qualità, Sicurezza, Ambiente, Energia e Agroalimentare, pronti ad essere spesi anche in contesti internazionali.
-92% di Placement Occupazionale, testimoniato dalle storie di successo nelle precedenti 86 edizioni con oltre 3.500 ex Allievi oggi assunti nelle più importanti aziende in tutti i settori dell’economia.
-Sbocchi Professionali: Responsabile/Auditor Qualità, Auditor Ambientale, Ecomanager, Esperto di Impatto Ambientale, Ispettore presso Enti di Certificazione, Consulente Sistemi di Gestione Aziendale, Responsabile Sicurezza RSPP, HSE Manager ed altre figure professionali in linea con il settore.

Per iscriversi:
Per iscriversi al Master è necessario prenotare sul sito di Uninform Group la selezione di accesso che consiste in un colloquio conoscitivo/motivazionale in video call Skype e nella valutazione, da parte dell’ufficio placement, del curriculum del candidato, degli studi effettuati ed eventuali esperienze svolte.

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Two Laboratory Assistant positions in the Wennerberg Group
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Employer: Copenhagen University

Place of employment
The Wennerberg Group at the Biotech and Research Innovation Center (BRIC), University of Copenhagen, is looking for two Laboratory Assistants for laboratory maintenance with effect from November 15, 2024.

The Wennerberg group at BRIC focuses on identifying new effective precision cancer therapies. This is done with a systems-driven approach where we combine chemical biology, phenotypic profiling, molecular profiling, and informatics to gain an understanding of individual cancers, their drug resistance mechanisms, and how they may be targeted. Our goal is to build the foundation for new types of stratified and individualized curative treatment strategies for cancer patients.

We offer creative and stimulating working conditions in dynamic and international research environment. Our research facilities include modern laboratories, and several core facilities shared between the 24 research groups at BRIC and the neighbouring Finsen Laboratory.

Responsabilities
We are looking for two part-time employees who want to help us with our routine laboratory duties. The jobs entail maintaining our laboratory supplies together with fulfilling weekly cleaning duties. More specifically, your tasks will include:

  • Revising our stocks of general laboratory supplies (i.e., culture plates, pipette tips, PBS, etc.).
  • Filling in order forms for the products that are low in stock.
  • Perform weekly cleaning of our cell lab including incubators, water baths, and LAF benches according to our cleaning guidelines.

Working hours are expected to be divided over 3-4 days/week for a total of 12 h/week.

Requirements
We are looking for a highly motivated and enthusiastic individual to help us out as a laboratory assistant.

  • We expect that you have an ongoing bachelor’s and/or master’s biology education.
  • We also expect that the successful candidate is systematic, detail-oriented, and self-driven.
  • Previous laboratory and research work experience, as part of courses, internships, or employment is a plus.

Terms of employment
Starting date is as soon as possible, with November 15, 2024, being the desired start date. The employment as Laboratory Assistant is a fixed term and part-time position with an average of 12 working hours per week until January 31, 2026.

The employment is made in accordance with the Collective Agreement between the Danish Ministry of Finance and the Organisations of Public Employees – governmental institutions (the OAO-S collective agreement) and the Professional Agreement for clerical employees, laboratory technicians and IT officers in the state.

Further information
For further information please contact Krister Wennerberg, 
krister.wennerberg@bric.ku.dk

 

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Addetto/a al Controllo Qualità Analitico e Documentale
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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it), la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale.

 Per azienda cliente che produce nella Cosmetic Valley lombarda linee complete di make-up per i grandi marchi internazionali, ricerchiamo:

Addetto/a al Controllo Qualità analitico e documentale

I prodotti di cui ti occuperai sono: skincare, body care, baby care, fotoprotezione e profumi.

Sede: provincia di Monza e Brianza

Contratto: assunzione diretta a tempo indeterminato, CCNL Chimico.
Remote working: 2 giorni a settimana.

Inserimento previsto entro novembre 2024.

Responsabilità:

  • Controllare materie prime, semi-lavorati e qualsiasi componente del processo produttivo compreso il prodotto finito.
  • Rilevare e segnalare difetti di standard.
  • Proporre idee per migliorare il livello qualitativo o eliminare eventuali difetti rilevati.
  • Pianificare e svolgere i controlli d'ispezione.
  • Scegliere i campioni da ispezionare o da testare.
  • Testare parametri di analisi con strumentazione di laboratorio.
  • Interfacciarsi con laboratori esterni per le analisi microbiologiche  Preparare i certificati di qualità.
  • Tenere traccia dei difetti riscontrati, conservare e aggiornare la documentazione e le schede tecniche  Restare in continuo aggiornamento su protocolli, tecniche e norme.

Requisiti:

  • Esperienza di 1 anno nel ruolo.
  • Buone capacità comunicative, spirito collaborativo, organizzazione e attenzione al dettaglio.
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Production & Process Development Officer
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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

Per azienda cliente specializzata nello sviluppo, produzione e commercializzazione di principi attivi farmaceutici (Generici APIs, Citotossici APIs, Peptidi APIs), ricerco

Production & Process Development Officer

Sede: Cinisello Balsamo (MI)

Contratto: iniziale contratto a tempo determinato, CCNL Chimico Farmaceutico, livello di inquadramento e retribuzione in base all’esperienza maturata.

Responsabilità:
Nell’ambito delle attività R&D, su richiesta Supervisore R&D, in accordo con Il Coordinatore di Produzione, supporta sperimentalmente i ricercatori nello svolgimento delle loro attività, sui progetti attivi nell’Unità Peptidi.

  • Esegue prove di laboratorio per implementare processi e/o attività di troubleshooting e attività di messa a punto di metodiche analitiche, metodiche di sintesi e di downstream per le fasi di ricerca e sviluppo, operando nel pieno rispetto delle buone regole di laboratorio sulle quali è adeguatamente addestrati.
  • Collabora nella stesura ed emissione di Fogli di Lavorazione o Fogli di Bonifica, per processi di prodotti in sviluppo (R&D) o produzioni GMP e di procedure interne.
  • Opera nel pieno rispetto delle normative GMP e di sicurezza, sulle quali è adeguatamente addestrati.
  • Lavora nei Reparti di Sintesi Chimica e/o Purificazione.
  • Conduce in base a metodi di lavoro prestabiliti e in completa autonomia operativa una linea di produzione e/o una tipologia di prodotti.
  • Controlla i parametri di funzionamento delle macchine contribuendo alla loro messa a punto e regolazione.
  • Garantisce per il corretto smaltimento dei reflui prodotti durante l’esecuzione delle lavorazioni di Reparto.
  • Gestisce per le parti di sua competenza e supporta l’attività legata al mantenimento in buono stato di apparecchiature, impianti e strutture dei Reparti di Produzione.
  • Garantisce il buon funzionamento e l’aggiornamento della documentazione dei Magazzini Materie Prime, Semilavorati e Finiti Vendita.

Requisiti:

  • Laurea chimica industriale, CTF, chimica.
  • Buona conoscenza della lingua inglese sufficiente alla gestione delle attività routinarie.
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Junior Automation Engineers Pipeline
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Employer: Novo Nordisk - Denmark

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Locations: We are looking for candidates to all our locations. This specific pipeline covers on-site positions in Kalundborg.

The Role & Department
Are you ready to take the next step and pursue a life-changing career at Novo Nordisk? Are you driven by automation and digitalization of the Novo Nordisk manufacturing value chain? Look no further!
We are building a talent pipeline for Junior Professionals to join Novo Nordisk in shaping the future through automation.

Joining the Automation Engineers Pipeline

By applying for the pipeline, you will be considered as a potential match for on-site automation related positions, which align with your background, skills, and interests across various areas in Denmark.

 

Due to the expansion of our activities in all business areas and sites, we are currently seeking talents for many different teams across Novo Nordisk, such as Advanced automation, Manufacturing Execution Systems (MES), and Collaborative- and industrial robotics. We encourage you to read more detailed information about the different roles and areas through this link: https://www.novonordisk.com/careers/campaigns/automation-engineer-process-digitalization.html

Requirements
We are looking for someone with an innovative and solution-oriented mindset. As you will be working and collaborating with people from various departments in the organization, it would be preferable that you are ready to take the lead on deploying solutions that bring value.

To apply to our pipeline, we expect that you:

  • Are newly graduated with a bachelor’s or master’s degree within e.g., IT, Automation, or Robotics
  • Would like to build on your skills and experience together with highly dedicated colleagues.
  • Are proactive, solution-oriented, like to share your knowledge and collaborate effectively.
  • Work systematically and with the ability to develop and implement practical actions to deal with issues.
  • Have proficient oral and written communications skills in English. Danish language skills are great advantage.
  • As documentation according to Good Manufacturing Practice (GMP), rules are part of our daily work, it is important that you thrive in ensuring that all your work is well documented.

 

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Regulatory Affairs
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In partnership con prestigiosa azienda che produce e commercializza make-up e cosmesi skincare a livello globale, eccellenza del made in Italy, offriamo due interessanti e stimolanti opportunità in ambito Affari Regolatori.

REGULATORY AFFAIRS – settore COSMETICO: junior e senior

Sede di lavoro: CREMA
Contratto offerto: Contratto a tempo indeterminato, CCNL Chimico Farmaceutico.

Principali attività:

  • garantire conformità di prodotto e semilavorato rispetto alle normative europee ed extra-europee
  • gestire la documentazione tecnica per autorità regolatorie e clienti e monitorare i relativi aggiornamenti
  • redigere ed aggiornare i documenti di registrazione in collaborazione con i principali riferimenti interni in ambito Sales & Marketing, Qualità, R&D, Produzione, Logistica
  • verificare le specifiche normative per i paesi UE, Extra UE e UK per definire le corrette procedure di spedizione in presenza della documentazione corretta
  • gestire direttamente eventuali problematiche con la dogana

Requisiti:

  • scolarità scientifica / legale o percorso di studi specifico per il ruolo.
  • solida esperienza effettuata in medesimo ruolo e presso aziende appartenenti al settore cosmetico.
  • È richiesta buona conoscenza delle normative specifiche che regolano il settore (MDR 2017/745, MDD, MDSAP) della gestione diretta di Audit e autonomia di utilizzo della lingua inglese.
  • Ottime capacità comunicative e relazionali per un’ottimale collaborazione con colleghi, enti, clienti e con il team di riferimento, capacità organizzative e predisposizione al problem solving completano il profilo.
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Quality Control Analyst del Laboratorio Chimico
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Main Activities
- Svolgere attività analitiche specialistiche nel campo analitico-strumentale.
- Operare con autonomia all'interno dei lavori che gli vengono affidati dal Supervisore che lo coordina, nell'ambito di obiettivi prefissati o discussi.
- Eseguire tutte le operatività del laboratorio. Interagire autonomamente con altri laboratori / unità, nello svolgimento del lavoro affidatogli. Riportare autonomamente per iscritto i risultati di lavoro.

Fornire supporto per:
- Mantenimento dello stato di qualità dei laboratori, mediante il monitoraggio dello stato di pulizia, ordine e stato fisico (pareti, pavimenti ed arredi);
- Verifica della presenza di DPI, etichette per tossici e nocivi e corretto stoccaggio dei rifiuti;
- Verifica dello stato di calibrazione e manutenzione delle attrezzature (mediante controllo etichetta e del logbook);
- Controllo della strumentazione di stoccaggio (armadi aspirati) presente nei locali di competenza;
- Controllo dei materiali e i reagenti mediante verifica delle scadenze, stoccaggio idoneo e presenza dei MSDS.

Release Analitici:
- Eseguire le analisi e prove (Controlli chimico-fisici e biochimici) al fine di permettere il controllo efficiente ed affidabile delle materie prime, dei processi, degli API, intermedi e delle utilities (acqua
di processo e condensa del vapore puro) nel rispetto delle procedure e dei programmi stabiliti
- Eseguire le attivita analitiche del laboratorio chimico-fisici e biochimici degli studi di stabilità;
- Eseguire il campionamento delle materie prime;
- Eseguire il campionamento delle utilities (Acque di Processo e Condensa del Vapore pulito);
- Eseguire il controllo della cleaning degli impianti (Swab tests ed analisi delle Rinse water).

Laboratory Documentation Management and Training:
- Redigere le procedure del Laboratorio Chimico di sua competenza prima del loro utilizzo;
- Redigere Memo e Report analitici;
- Notificare tempestivamente i risultati non conformi ed eseguire le Investigazioni di Laboratorio, nella gestione degli OOS;
- Redigere documentazione su richiesta del responsabile.

Indagini /Deviazioni /Reclami /Change request:
- Comunicare ed assicurare che le deviazioni relative ad attività legate alle analisi di sua competenza siano opportunamente indagate e risolte;
- Assicurare che le CAPA relative assegnatele siano eseguite nei tempi prescritti,
- Comunicare ed assicurare che le Change requests relative ad attività di competenza siano opportunamente gestite e completate.

Collaborations:
- Fornire supporto tecnico per audit interni;
- Partecipare attivamente alla preparazione delle ispezioni.
- Fornire supporto tecnico per le qualifiche delle utilities/equipment.

Technical skills
• Elettroforesi (gel and capillary)
• Spettrofotometria
• FTNIR
• ELISA Test
• Test Enzimatici
• Test Cromatografici
• Esperienza nei software cromatografici come EmpowerTM.

 

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Field Application & Service Specialist
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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale.

Per rafforzamento del team di multinazionale operante nel settore della diagnostica molecolare, in particolare di soluzioni e test diagnostici molecolari per l'individuazione di agenti infettivi, ricerchiamo un/a:

FIELD APPLICATION & SERVICE SPECIALIST – CENTRO-SUD ITALIA

Zona di lavoro: Napoli/Roma con spostamenti e trasferte su tutto il Centro-Sud Italia

Contratto: a tempo indeterminato; CCNL Farmaceutico, Livello commisurato al livello di professionalità acquisito.
Si offre: Benefits correlati alla posizione quali, pc, cellulare, auto aziendale ad uso promiscuo.

Responsabilità:

  • Organizza ed effettua training tecnico-applicativi presso le sedi degli utilizzatori;
  • E’ referente diretto per domande tecniche ed applicative;
  • Svolge presentazioni tecnico scientifiche sulle soluzioni offerte;
  • Supervisiona, educa ed aiuta i clienti acquisiti nell’utilizzo ed applicazione dei prodotti diagnostici (strumentazione e reagenti);
  • Prende parte a congressi e convegni scientifici del settore; collabora e supporta la rete vendita di zona;
  • Gestisce delle fasi di prevendita e postvendita;
  • Pianifica ed esegue in autonomia attività di installazione, assistenza e validazione delle apparecchiature con la garanzia del necessario approvvigionamento dei pezzi di ricambio;
  • Risolve problemi, diagnosi e correzione in caso di malfunzionamenti del sistema;
  • Analizza i dati strumentali e di laboratorio per attività di troubleshooting, per proposizione e valutazione della soluzione offerta rispetto alla routine attuale e per l'ulteriore sviluppo dei processi di supporto interno.

Requisiti:

  • Laurea in discipline scientifiche o ingegneria (Biologia, Biotecnologia, Ingegneria Biomedica);
  • Pregressa esperienza di almeno 1 anno con macchine da laboratorio di diagnostica anche complesse (la conoscenza del sistema di preparazione dei campioni automatico da laboratorio è considerata un forte plus);
  • Ideale la pregressa esperienza di laboratorio su tecniche di Biologia Molecolare;
  • Esperienza professionale nel trattare con i clienti;
  • Gradita una buona conoscenza della lingua inglese;
  • Buona conoscenza del pacchetto office e dei principali software informatici
  • Elevata determinazione nel raggiungimento dei risultati;
  • Ottime capacità relazionali e di comunicazione orale e scritta;
  • Capacità di lavorare in modo autonomo, attento e strutturato;
  • Buona metodologia di troubleshooting anche durante situazioni pressanti ed in emergenza;
  • Flessibilità e dinamicità
  • Disponibilità a viaggiare frequentemente sul territorio (anche 3-4 giorni alla settimana);
  • Patente B.
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Laboratory Technologist (Laborant) within biology and translational research
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Employer: Aarhus University

The Department of Biomedicine at Faculty of Health at Aarhus University invites applications for a position as a laboratory technologist within biochemistry, medical biology and translational research as per 1 January 2025 or as soon as possible thereafter. The position is a permanent full-time position.

The Department of Biomedicine prioritises diversity and a good work environment, as this is a prerequisite for groundbreaking research. In a diverse and international research environment, dedicated employees are looking to generate new knowledge within biomedical research areas such as infection and inflammation, membranes, neuroscience and personalised medicine. The Department of Biomedicine provides research-based teaching of the highest quality and is responsible for a large part of the medical degree programme. Academic staff contribute to the teaching. English is the preferred language in the laboratory, at meetings and at seminars. The department employs approx. 500 people from all over the world, and they make use of the department's modern laboratory-, core- and animal facilities. The Department of Biomedicine focuses on innovation, entrepreneurship and collaboration with business and industry, and numerous researchers from the department have established companies to develop new medicinal treatments founded in professional scientific basic research. 

Responsibilities

As laboratory technologist, your primary tasks consist in performing multiple biochemical analyses as well as managing samples storage and preparation. You contribute also to the general laboratory operation of the team and the operational and maintenance of laboratory equipment. In your daily work, you have a close interaction with competent colleagues in a stimulating environment.

Your main tasks will consist of:

  • Collection, storage, and preparation of samples from mouse and human origine
  • DNA, RNA, and protein extraction
  • Measure of genes and proteins expression (PCR, Western blotting)
  • Operation and maintenance of laboratory equipment
  • Management of laboratory consumable and procurement

You will report to group leader, Professor Frederic Gachon.

Requirements

  • You have a background as Laboratory technologist (laborant) or Medical Laboratory Technologist (bioanalytiker).
  • Experience and training in animal experimentation.
  • The work language will be English and a reasonable level of understanding, writing, and speaking in English is required.
  • You have good interpersonal skills.
  • Inclusive and team-oriented and able to contribute to a good work environment.

Terms of employment
Terms of employment and pay are regulated by the collective agreement between the Ministry of Taxation and the Organisations of Public Employees, Denmark (OAO) or the Danish Confederation of Public Employees of 2010 (LC/CO10).

 

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QC Technicians in Process
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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it)la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

2 Quality Technicians in process

I Quality technicians verranno inseriti/e nella linea “Modern Oral”, prodotti per uso orale, che contengono nicotina ad alta purezza, acqua e altri ingredienti alimentari di alta qualità.

Sede: Trieste (TS)

Contratto: a tempo determinato/indeterminato, CCNL Chimico Farmaceutico.
Orario di lavoro: full time, ciclo continuo | Disponibilità a lavorare su tre turni da lunedì a venerdì.

Responsabilità:

  • Campionamento e rilevazione di eventuali non conformità durante la produzione.
  • Controlli in process durante la produzione (es. relativi a peso, misura) prodotti per uso orale HACCP.
  • Controlli in process durante la produzione (es. relativi a peso, misura, pH, dimensioni) e redazione di certificati analitici sulla base di specifiche predefinite per prodotti farmaceutici.

Requisiti:

  • Laurea in materie scientifiche.
  • Esperienza di almeno 6 mesi maturata nell'area Controllo Qualità in siti produttivi farmaceutici o alimentari, utilizzando GC e SPETTROSCOPIA.
  • Conoscenza delle normative HACCP e/o GMP.
  • Richiesta la conoscenza della lingua inglese.

Completano il profilo:

  • Buone capacità di comunicazione.
  • Sapere lavorare in autonomia nel rispetto delle normative Qualità HACCP/GMP.
  • Capacità organizzative e di pianificazione. 
  • Propensione al lavoro in team e flessibilità.
  • Propensione alla collaborazione e alla condivisione del proprio know-how.

BAT TRIESTE è parte del Gruppo BAT, fondato nel 1902, con sede a Londra. Leader mondiale nei beni di largo consumo con un portafoglio prodotti multi-category nel settore del tabacco, BAT impiega oggi oltre 52.000 persone, opera in più di 175 mercati e ha 75 stabilimenti produttivi su scala globale.

A settembre 2021 BAT Italia ha annunciato la costruzione dell’ ”A Better Tomorrow™ Innovation Hub", nella città di Trieste: un centro di innovazione e sostenibilità di livello mondiale per un investimento totale fino a 500 milioni di euro in 5 anni. Uno spazio di oltre 20mila metri quadrati che oltre ad ospitare un nuovo centro di produzione per i prodotti a potenziale rischio ridotto di BAT (in cui saranno sviluppati anche dei prodotti per la terapia sostitutiva della nicotina), ospiterà anche una Digital Boutique, ossia un laboratorio di innovazione e centro di eccellenza per la trasformazione e l'accelerazione digitale di BAT.

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QC Chimico
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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

In collaborazione con Azienda farmaceutica che produce e commercializza prodotti sterili e liofilizzati, siamo alla ricerca per il plant di Ferentino (FR) di due risore:

2 ANALISTI/E DI LABORATORIO CHIMICO (QC)

Si richiede disponibilità immediata e flessibilità a lavorare su turni.

Contratto: diretto con l'azienda, il livello di inquadramento verranno commisurati all'esperienza del candidato.

Responsabilità:

  • Esecuzione di test qualitativi e quantitativi per le analisi di materie prime e prodotti finiti.
  • Attività analitica relativa ad analisi in process, prodotti bulk ed utilities.
  • Attività analitica relativa a studi di stabilità ed analisi di rilascio.
  • Attività analitica relativa a convalide analitiche e transfer con i Clienti.
  • Utilizzo delle principali tecniche di laboratorio e strumentazione di laboratorio chimico.
  • Compilazione e gestione della documentazione analitica.

Requisiti:

  • Laurea ad indirizzo scientifico (CTF, Chimica, o similari).
  • Buona conoscenza della lingua inglese.
  • Almeno 1/2 anni di esperienza nella mansione.
  • Buona capacità di lavorare in team.
  • Buona capacità di organizzazione del proprio lavoro.

 

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Graduate Programs - GN Group
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Employer: GN Group

The GN Group will soon be launching their Graduate Programs which will be open to 15 recent graduates in the fields of Engineering, Finance, Marketing, Information Technology, Supply Chain and Business.

It offers you a unique opportunity to make a true difference in people’s everyday lives. As a GN Graduate you will experience a great network of peers, a steep learning curve, management exposure, and get a unique opportunity to develop personal and professional skills in a global setting.

Our long-term plans include you!

Apply for one of our six tracks:

  1. Engineering
  2. Finance
  3. Marketing
  4. IT
  5. Supply Chain
  6. Business

How it works?
We offer a two-year cross-functional program with 3 rotations of eight months duration. You will spend the 2nd rotation abroad in one of our many subsidiaries around the globe.
You will get included as every other employee in the company and you will work on your own projects during each rotation. As you are considered to be an employee you will be paid a full time salary with pension and other benefits.
During the 2 years that the program lasts, you will be prepared for a career in GN, and we will support you in finding a position in the company during your third rotation.

When does the Graduate Program start?
The recruitment window will open from October 2024, the Graduate Program will start on September 1st 2025.

For foreign students:
We are a multi-cultural and inclusive company, so the only language we require is English.
And even though you are still on your Master, we hope to get an application from you, so you can start your career with us when you finish your education.

Further information: 
https://www.gn.com/Working-with-us/Graduate-Program

⚠️ To submit your application, please go to the following site:
https://www.gn.com/Working-with-us/Graduate-Program

-

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Student opportunities at at Novo Nordisk Engineering
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Employer: Novo Nordisk Engineering (NNE)

As a company NNE value the knowledge that student workers, interns and thesis writers bring to their company. NNE offers specific opportunities for motivated and ambitious students who are eager to pursue careers in the pharmaceutical industry:

  1. Student internships
  2. Student jobs
  3. Master’s thesis projects


1. STUDENT INTERNSHIPS

An internship will provide you with valuable work experience and inside knowledge of the various types of positions and responsibilities at NNE. An internship usually lasts three to six months and assignments vary. Positions are both paid and unpaid and become available throughout the year.

Who can apply?
NNE’s student internship program is designed for students who are enrolled in a degree program (BSc, MSc or MBA degree level) at an accredited college or university.

Engineers
The internships for engineering students are targeted at academic majors in:

  • Automation
  • Architecture and design
  • Structural engineering
  • Civil engineering
  • Mechanical and electrical engineering
  • Chemistry, food, biotechnology, dairy, food science or similar areas

Other areas
We also offer internships in the following areas:

  • Finance/project economy
  • Human resources
  • IT 
  • Purchasing
  • Sales and marketing

2. STUDENT JOBS
Gaining work experience is the perfect way to get a better understanding of roles and assignments you wish to engage in once you finish university. You will obtain valuable industry insight and learn more about yourself, your strengths and your development potential.

We offer between 10-20 hours a week all depending on how you can combine the job with your studies, as we know you need the flexibility, also around holiday and exam periods. Few positions are full-time positions.

Responsibilities
The responsibilities of student staff range from providing customer service and technical support, preparing for and participating in events held by our offices to assisting with various projects as needed.

Who can apply?
Student jobs are designed for students who are enrolled as degree-seeking students at an accredited college or university. Student jobs are available at all our offices worldwide and are posted as needed.

Requirements
You are enrolled in a university or college program.

3. MASTER’S THESIS PROJECTS
A Master’s thesis project is a way for us to get to know you as a student and also to learn about the latest developments in the academic world. Working on a Master’s thesis is your first step into working life and, we hope, a new acquaintance with NNE.

Who can apply?
We invite Master’s degree students to use NNE as a case study in dissertations or major projects within:

  • Automation
  • Architecture and design
  • Structural engineering
  • Civil engineering
  • Mechanical and electrical engineering
  • Chemistry, food, biotechnology, dairy, food science or similar areas

Available case projects
When we have Master’s thesis projects available, we list them on our career site at www.nne.com. If no projects are announced, but you have your own idea that you think could be implemented together with us, you are welcome to contact us.

⚠️ To submit your application, please go to the following site: 
https://www.nne.com/careers/entry-level/

 -

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Computer System Validation (CSV) Intern
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Ruolo: CSV Intern

Sede: Latina e/o da remoto con disponibilità a viaggiare su tutto il Territorio Nazionale secondo le necessità di progetto per il raggiungimento degli stabilimenti dei clienti.
Contratto: iniziale stage extracurriculare, finalizzato ad assunzione in apprendistato.
Orario di lavoro: full time

Disponibilità: Immediata

S4BT è un’Azienda di oltre 80 specialisti e specialiste, che da quasi 30 anni fornisce soluzioni software e consulenze per il settore Life Science e non solo, in diversi ambiti come qualità, ingegneria, Project
Management, Validazioni, Tech Transfer, Computer System Validation e altro.
Proprio per l’area Computer System Validation, ricerchiamo un profilo neolaureato che, grazie al supporto di un tutor, intraprenderà un percorso formativo tale da ricoprire il ruolo di CSV Intern.

Come CSV Intern, di cosa ti occuperai?

♦︎ Avrai l’opportunità di intraprendere un percorso formativo che ti permetterà di eseguire attività di progetto in ambito Computer System Validation (redazione di documenti ed esecuzione in campo di protocolli di test, per la convalida dei sistemi computerizzati utilizzati in ambito GxP) in termini di:

  • Partecipazione a corsi di formazioni erogati all’interno dell’azienda.
  • Affiancamento nei progetti assegnati.

♦︎ Parteciperai a meeting di condivisione di progetto e di area con tutto il team CSV.

Cosa ci piace in un/a candidato/a?

  • Un/a vero/a team player, capace di favorire confronti costruttivi, condividere informazioni e fornire feedback sul proprio lavoro.
  • L’attitudine a far proprie le linee guida aziendali.
  • La curiosità, l’entusiasmo e l’energia.
  • La partecipazione e la proattività verso iniziative legate a progetti interni all’azienda.

Cosa richiediamo?

  • Laurea triennale o magistrale in discipline tecnico-ingegneristiche e chimico-farmaceutiche.
  • Interesse e curiosità nella convalida di sistemi computerizzati ed infrastrutture di rete.
  • Interesse e curiosità in ambito Quality Assurance and Compliance.
  • Buona conoscenza della lingua Inglese sia scritta che parlata (livello minimo B1).
  • Buona conoscenza del pacchetto Office.

Se ti interessa la posizione vieni a conoscerci a Roma, il 29 ottobre 2024, oppure contattaci su LinkedIn!

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Graduate Programme - Demant
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Employer: Demant

The Graduate Programme at Demant offers you a unique opportunity to develop your personal and professional skills in a great working environment. You will join us in improving the lives of millions of people worldwide through hearing health.

We offer 10 different tracks:

  1. Commercial Excellence
  2. Global Business
  3. Intellectual Properties
  4. Operations
  5. Finance
  6. Tax
  7. Audiology
  8. Legal 
  9. Engineering 
  10. Commercial 

How it works?
Each track will take you through three or four rotations in a two-year journey. During your rotations, you will get hands-on experience with different challenging projects that allow you to learn and build on your knowledge and skills. We are a global company, so all tracks are designed with an international perspective, in fact, many of our graduates also have the opportunity to go abroad for one rotation. 

After successfully completing the Programme, we offer you a permanent position with Demant - either in Denmark or abroad. However during the Graduate Programme graduates receive a full-time salary from the start.

As a graduate, you will have an introduction week in the beginning, training bootcamps, visits to our business sites, as well as management meetings. Also, we offer you a beneficial health insurance, a wide range of sporting and leisure clubs including offer for massages, a healthy and delicious canteen, and lot of fun activities and events with the other graduates.

When does the Graduate Program start?

For foreign students:
Demant is an international company, and our business language is English. It is possible to apply for the Graduate Programme before you graduate, as long as you complete your studies before the start of the Programme.

Further information: 
https://www.demant.com/jobs-and-career/graduate-programme

⚠️ To submit your application, please go to the following site:
https://www.demant.com/jobs-and-career/graduate-programme

 

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Principal Category Manager
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Employer: Ferrosan Medical Devices

The Role & Department
Do you want to be responsible for developing our Sourcing of Plastic suppliers to new heights? Do you want to make a difference for patients undergoing surgery by securing the compliance of the medical devices used by healthcare professionals? 

Here you have the opportunity to get an exciting and challenging job, as Principal Category Manager, in a international company. As Ferrosan Medical Devices is growing, you will be able to shape the job in our Strategic Sourcing Department to a large extent. The position refers to the Senior Manager of Strategic Sourcing.

The department Strategic Sourcing is part of Supply Chain Management, which is a central area in Ferrosan Medical Devices. Strategic Sourcing consists of 6 experienced Category Managers covering direct spend, CMOs and Indirect spend including equipment and machinery. The team is responsible for all aspects of supplier management including supplier selection, negotiation, and collaboration as well as risk mitigation, spend/savings program, and category strategies. 

Responsibilities
You get a central position, with responsibility for the collaboration and development of the company's Plastic Suppliers. There will be a great deal of contact with the suppliers, who are primarily in Europe, as well as a broad contact surface across Ferrosan Medical Devices.

Your main tasks will be:

  • Establishment and maintenance of Category strategies.
  • Daily handling and collaboration with our current Suppliers.
  • Negotiations and conclusion of contracts.
  • Development of the supplier base.
  • Optimizing the processes and structure around the Suppliers.
  • Participate in various product development and optimization projects

The overall purpose of the position is to ensure robust cooperation and management of our Plastic suppliers, this to reduce total costs through close cooperation, taking quality, reliability and risk management into account.

To be successful, you must internally work closely together with e.g. Finance, the Development department, the Quality organization and your colleagues in Supply Chain Management and Operations.

Your profile
The ideal candidate for the job holds experience from a similar role managing and leading Categories from a highly regulated industry such as medical devices, pharma, biotech, life science or similar. As a person you have a pragmatic approach, and you find solutions to identified problems.

  • Minimum B.Sc. – ideally a degree at M.Sc. level as an Engineer, Economist or within Supply Chain.
  • Minimum +5 years of experience within purchasing and/or Supply Chain.
  • You have experience with Category Management and supplier handling.
  • Demonstrated track record in finding pragmatic solutions to complex or challenging problems.
  • Highly experienced in stakeholder management.
  • Your work style is involving and impactful.
  • You think in holistic terms and with a business-oriented approach to the solutions.
  • You have created visible results in your current or previous roles.
  • You have experience with GMP.
  • Possess strong oral/written communication skills in English.

We offer
We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  
 
We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun😊. 

 

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Value & Access Specialist – Health Economics
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Place of work: Pisa (onsite position)

Type of contract: internship – possibility of permanent employment at the end of the internship period (hybrid work)

What will you deal with?

  • Supports development of P&MA assessments: overview of Italian landscape and competitors in the specific therapeutic area, identification of potential issues and hurdles.
  • Supports the adaptation of economic models: Budget Impact Model (BIM) and cost-effectiveness model (CEM) and writing of the Economic Section of the AIFA P&R Dossier.
  • Supports preparation of Pricing and Reimbursement (P&R) dossiers according to the Italian AIFA requirements (any kind of dossier, from medicinal specialties to generics, from new applications to renegotiation applications, etc.), and submission to the Italian Agency.
  • Supports logistics of advisory boards with KOLs and/or payer experts (recruitment, contracting, reporting) and Face2Face/telephone interviews (recruitment, contracting, interview, reporting).

What are the requirements?

  • Master's degree in Pharmaceutical Chemistry and Technology or Economics, with specialization in Health Economics.
  • Excellent knowledge of English (written and spoken), essential for frequent contacts with international companies.
  • Ability to work in a team and aptitude for learning.

What we offer?

  • Dynamic and challenging work environment with international projects.
  • Ongoing training and opportunities for professional growth.

 

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Clinical Drug Supply Manager
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Employer: GENMAB

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
Genmab is searching for an experienced Clinical Drug Supply Manager to be part of Global Clinical Drug Supply Operations in Copenhagen, DK or Princeton, NJ in commuting distance to our office locations to work according to our hybrid work arrangement.

Moving forward with many late-stage trials in pipeline, the Clinical Drug Supply Manager will be managing outsourcing of packaging, labelling, and distribution of clinical trial supplies for early as well as late stage Genmab clinical trials. The Clinical Drug Supply Manager will work closely with GMP QA and our CMOs ensuring timely packaging and labelling for our clinical trials as well as IST and PAA for patients with cancer and other serious diseases.

The Clinical Drug Supply Manager must have extensive knowledge of cGMP and have a focus on the level of quality in work performed.

The position reports to the Director of Global Clinical Drug Supply Operations based in Copenhagen.

Responsibilities

  • Manage and coordinate drug supply and to provide IMP for clinical trials, IST, and Pre-Approval Access Programs.
  • Manage and coordinate ancillaries, pre-medication, and comparators for clinical trials.
  • Set-up English Master Label, manage label translation without vendor and approval of label proofs/designs.
  • Manage set-up of distribution framework through service providers.
  • Define appropriate drug supply activities at CMO necessary for providing drug supplies for clinical trials.
  • Contribute to maintenance of SOPs and Work Instructions in the department.
  • Perform training of other team members.
  • Function as Subject Matter Expert within relevant areas.
  • Responsible for being compliant with Genmab’s quality system.

Requirements

  • At least 3 years’ experience in handling clinical drug supply, including setting up label text and handling of ancillaries.
  • Ability to manage stakeholders internally and externally.
  • Experience working with CMO for clinical trial supplies.
  • Training in GDP, GMP and GCP is a requirement.
  • Experience working with IST and PAA from a Sponsor perspective will be an advantage.
  • Excellent communication skills in English - both oral and written.

Moreover, you meet the following Personal Requirements

  • You can structure and organize your work.
  • You are process oriented and contribute to continuous improvements.
  • You have a quality mindset and can prioritize your work in a fast paced and changing environment.
  • You have good interpersonal and communication skills.
  • You can work independently as well as within global teams.
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to grapple with the unknown and be innovative
  • You have experience working in a fast-growing, dynamic company (or a strong desire to)
  • You work hard and are not afraid to have a little fun while you do so

The Team
You will be part of a highly competent team focused on packaging and labelling of supplies for clinical trials, working closely with the Global Clinical Drug Supply Planning team and our CMOs.
Together with Global Clinical Drug Supply Systems team the three teams make up the Global Clinical Drug Supply department.
We have an international and informal working environment with a high pace while having fun and focus on one team spirit both within and outside the team and department.

 

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Master Batch Record Specialist
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HiRevo LifeScience è la specializzazione di Gi Group dedicata alla Ricerca e Selezione di profili in ambito Operation, Quality, Regulatory, R&D, Clinical Research e Sales & Marketing dei settori Farmaceutico e Medicale

Proponiamo un’interessante opportunità come:

Quality Assurance Specialist – Master Batch Record 

L’azienda nostra cliente è un’azienda globale leader nella produzione di farmaci sterili.

Sede: Monza, sede raggiungibile facilmente da Milano anche con servizio di navetta gratuita dalla Stazione di Monza.

Contratto: di 12 mesi, scopo assunzione, CCNL Chimico Farmaceutico, livello C2. Mensa, smart working 3 giorni su 5 una volta raggiunto un buon livello di autonomia.

Responsabilità:

  • I candidati scelti verranno inseriti all’interno del Master Batch Record Team che fa parte del dipartimento MS&T (Manufacturing, Science and Technology), dipartimento multifunzionale e multidisciplinare che lavora al trasferimento di commesse - da R&D o da altri stabilimenti – sulle proprie linee produttive.
  • I candidati scelti verranno formati e affiancati fino a raggiungere autonomia professionale nella scrittura e gestione documentale del documento Master Batch Record alla base di ogni processo produttivo farmaceutico GMP.
  • Lavoreranno a stretto contatto con le altre funzioni del MS&T (Regolatorio, al Tech Transfer, tecnologia di processo, project manager, etc) e con i clienti stessi a livello Global, acquisendo una overview privilegiata dei processi e degli impatti regolatori, di processo e tecnologici sottostanti all’avviamento o alla modifica di ogni processo produttivo farmaceutico.

Requisiti:
Il profilo ricercato possiede:

  • Una laurea di II livello in ambito scientifico (preferibilmente in CTF).
  • Ha maturato un'esperienza di 6 mesi/1 anno, in ambito Quality di un’azienda produttiva farmaceutica.
  • Ha un’ottima conoscenza della lingua inglese.
  • L’aver visto o gestito il Master Batch record o l’aver effettuato Batch Record Review in formato elettronico costituisce titolo preferenziale. 
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Quality Control Bulk
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HiRevo LifeScience è la specializzazione di Gi Group Holding (www.gigroupholding.it)la prima multinazionale italiana del lavoro, dedicata a valorizzare le esperienze, le competenze e il potenziale dei candidati in ambito Sales & Marketing, Clinical Research, Regulatory e Operation dei settori Chimico-Farmaceutico, Cosmetico e Medicale. 

In partnership con tra le migliori aziende cosmetiche italiane del make e skincare, eccellenza del made in Italy, offriamo un'interessante e stimolante opportunità in ambito:

Controllo Qualità Bulk

Sede: provincia di Bergamo

Orario di lavoro: tre turni.

Responsabilità:

  • Esegue le analisi chimico-fisiche e organolettiche del bulk secondo le specifiche (presenti in Rete e prodotte dalla ricerca) e secondo le priorità assegnate.
  • Approva e permette lo scarico del bulk quando il prodotto è conforme alle specifiche.
  • Se il prodotto è fuori specifica, fornisce alla produzione dei metodi per correggere la formula solo nel caso di piccole variazioni. Per modifiche più importanti chiede il supporto alla Ricerca.
  • Produce il certificato di analisi (ok colore) dove sono presenti i dati analitici e di controllo colore (di processo), che viene inviato al cliente.
  • Effettua controlli “for cause” a supporto delle indagini per produzioni non conformi.

Requisiti:

  • Diploma chimico o scientifico;
  • Disponibilità su tre turni;
  • Saper utilizzare sistemi gestionali/ERP;
  • Conoscenza dei prodotti cosmetici (anidri, emulsioni e polveri);
  • Conoscenza delle principali tecniche analitiche del controllo dei prodotti cosmetici;
  • Conoscenza delle tecnologie produttive dei prodotti cosmetici;
  • Conoscenze delle norme di buona fabbricazione (GMP).
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Graduate Programme - Novo Nordisk (in Denmark)
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Employer: Novo Nordisk - Denmark

Turn your master’s degree into a global career​ from September 2025!

‎Our global Graduate Programme is designed to bring together change makers with a diversity of perspectives and equip them with the tools needed to accelerate their personal and professional development. The two-year programme allows you to explore the world while developing your career. You will be taken on three to four rotations around the globe where you will work in a fast-paced environment with plenty of growth opportunities. You will be exposed to different parts of the Novo Nordisk value chain while being challenged to explore your boundaries and reach your full potential. 

After successfully completing the programme, you will be equipped with professional and personal skills to embark on your global career with the guarantee of a position at Novo Nordisk.

We open for applications 1 November 2024 for graduate careers starting 1 September 2025.

What is the Graduate Programme?
The Graduate Programme is a two-year, global career journey with a minimum of three rotations including at least one rotation outside your home country. The destination depends on the specific graduate programme track but it could for instance be in one of the Novo Nordisk sites in Denmark, our International Operations (IO) Strategic Head Office in Zurich, an IO Regional Office or one of our many affiliates globally.

The Graduate Programme is Novo Nordisk’s flagship ‘Talent programme’. Many top leaders started their journey in Novo Nordisk as part of the graduate programme, including our CEO Lars Fruergaard Jørgensen.

Is the Graduate Programme paid?
Yes, the Graduate Programme is a full-time position, and we offer a competitive entry level salary. The compensation and benefits package includes components such as pension and health insurance, based on local terms and is applicable to the country you are hired in.

What are the programme track I can apply to?

♦︎ TECHNOLOGY: Revolutionising the pharmaceutical industry through manufacturing technology, digitalisation and data science.

♦︎ PHARMACEUTICAL DEVELOPMENT: Life-changing careers within research and development and trial management.

♦︎ BUSINESS, COMMERCIAL, MARKETING & HR: A range of opportunities across our Global Business functions in HQ as well as in our local affiliates.

♦︎ FINANCE: Developing the next generation of finance leaders across various finance functions

♦︎ PROCUREMENT & SUPPLY CHAIN: Bringing value to Novo Nordisk and making a difference to patients and society while getting to know the core of our business.

♦︎ LEGAL ETHICS & COMPLIANCE: Fostering and strengthening a culture of ethics and compliance while experiencing three jobs in just two years.

Application requirements
Applicants must have a recent and relevant master’s degree* and international experience; for example, working, volunteering or from studying a full semester abroad.

We imagine that you have no more than one year of relevant work experience after graduation, above average academic achievements, and the ability to relocate internationally. In addition, Novo Nordisk’s corporate language is English, so you will be fluent in written and spoken English.

*If you are applying for one of our graduate positions in Latin America the master’s degree criteria is waived. Instead, you have a bachelor’s degree and one to two years of relevant full-time work experience at the time of application. If you have a master’s degree, then you should have a maximum of one year work experience.

Does Novo Nordisk sponsor visas for international students?
Yes, all nationalities can apply to the programme. If selected, Novo Nordisk helps you secure your work visa. 

Do I need to speak Danish in order to apply for the Graduate Programme?
No, our corporate language is English, so speaking Danish is definitely not a requirement. There may be local language requirements for some International Operations (IO) tracks.
 
⚠️ To submit your application, please go to the following site: 
https://www.novonordisk.com/careers/early-career-programmes/graduate.html
 
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Farmacisti
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La Divisione LifeScience di Gi Group, prima multinazionale italiana del lavoro, è specializzata nella Ricerca e Selezione di profili specializzati nei settori Farmaceutico e Medicale e nella Ricerca e Selezione di Ottici e Farmacisti per i canali Retail/GDO.

Il nostro cliente è una società attiva nel settore della grande distribuzione, per te un’opportunità come:

FARMACISTA

La risorsa sarà inserita nella parafarmacia all'interno del punto vendita, in un contesto sicuro, con orari di lavoro su turni continuanti esclusivamente diurni e definiti.

Sedi: varie città in Italia.

Contratto: Tempo determinato ed indeterminato

Responsabilità:

  • Servizio di assistenza e consulenza specialistica qualificata alla clientela per i prodotti OTC, SOP, integratori, omeopatici e dermocosmesi;
  • Gestione cassa e ordini
  • Riordino dei prodotti in vendita

Siamo interessati a valutare risorse motivate al trasferimento, il cliente offre un contributo economico per i primi 6 mesi di contratto.

Requisiti:

  • Laurea in Farmacia o in Chimica e Tecnologie Farmaceutiche
  • Iscrizione all’Ordine dei Farmacisti
  • Spiccate doti comunicative e relazionali, orientamento al raggiungimento di obiettivi

Valutiamo candidati/e neolaureati non ancora in possesso di abilitazione, per un iniziale inserimento come addetti/e alle vendite in attesa dell’avvenuta iscrizione all’Ordine.

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Staff Scientist in Molecular Palynology at GLOBE Institute
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Employer: Faculty of Health and Medical Sciences University of Copenhagen

Place of employment
The place of work is at the Section for GeoGenetics, Globe Institute, University of Copenhagen. We offer supportive, creative, and stimulating working conditions within a dynamic and international research environment. Our research facilities include a LEAF GOLD certified molecular lab, designed for generating genomic-scale datasets from both modern and ancient specimens, complemented by high-capacity computational servers adept at handling such data.

The Role & Depertement
We invite applications for the position of Staff Scientist in Molecular Palynology. This role is a fixed-term position limited to a period of four years, commencing on 1 January 2025 or as soon as possible thereafter. The position will be based at the Globe Institute, University of Copenhagen.

The successful candidate will join the Conservation Palaeogenetics & Palaeoecology Group at the Section for GeoGenetics, led by Assistant Professor Ana Prohaska. We work at the interface of palaeoecology, ancient genetics, evolutionary biology, and conservation science to understand how species and ecosystems responded to past environmental change and how this understanding can inform conservation decision-making today. Our focus is on identifying and, where possible, recovering genetic diversity relevant to preserving Earth’s contemporary biodiversity into the future. For more information about the group and our research, please see: globe.ku.dk/research/geogenetics/prohaska-group.

Your work will be embedded within the newly awarded Ancient Environmental Genomics Initiative for Sustainability (AEGIS) funded by the Novo Nordisk Foundation. This interdisciplinary research initiative aims to build a more sustainable and secure food production system while also preserving biodiversity in cropping systems under climate change. Its approach is to produce new knowledge and develop innovative methodologies in ancient environmental DNA to identify important organismal associations and genetic adaptations relevant to future food security. The initiative brings together a large international network of researchers with expertise in genetics, ecology, evolutionary biology, plant sciences, computer science, statistics, geology, archaeology, and more.

Responsabilities
The successful candidate will join an exciting new research programme within the AEGIS aimed at advancing the recovery and analysis of ancient pollen DNA using state-of-the-art single-cell sequencing technologies. The main objective of this programme is to develop and employ high-throughput methods for reconstructing ancient plant genomes, which will be applicable to a wide range of plant species worldwide. The selected candidate will contribute to and support (1) the wet lab workflow for sequencing bulk and single pollen DNA in a clean lab setting, and (2) its application to fossil pollen records from various depositional settings, as part of AEGIS’s Data Engine.

The tasks include but are not limited to:

  • Responsibility for the daily operation of the instrumentation for pollen isolation and handling.
  • Responsibility for preparing pollen samples for extraction and library preparation and coordinating their submission to other laboratory pipelines.
  • Participation in the development and implementation of protocols for fossil pollen DNA extraction, library preparation and sequencing.
  • Participation in the establishment of the bioinformatic pipeline for the analysis of ancient pollen DNA data.
  • Technical support in planning and troubleshooting.
  • Participation in the scientific activities of the group and the initiative.
  • Keeping up to date with technological developments.
  • Work in close collaboration with other scientific staff and academics at the section.

Requirements
We are looking for a highly motivated and energetic candidate with the following competencies and experience:

Essential qualifications and skills

  • MSc degree in molecular biology, (paleo)ecology, genetics, evolutionary biology, or a related field.
  • Extensive experience in palynological analysis.
  • Demonstrated experience in molecular biology methods.
  • A genuine interest in developing and advancing wet lab methodologies and protocols.
  • Self-motivation, pragmatic mindset, strong work ethics, and good interpersonal skills.
  • Ability to organise time and work effectively and responsibly, independently and in teams.
  • Strong attention to detail with demonstrated skills in troubleshooting.
  • Enthusiasm to be part of an interdisciplinary research project and work collaboratively with scientists across a wide range of disciplines.
  • Fluency in both written and spoken English (due to the institute's international profile).

Desirable experience and skills

  • PhD in molecular biology, (paleo)ecology, genetics, evolutionary biology, or a related field
  • Knowledge of ancient DNA laboratory techniques.
  • Knowledge of single-cell laboratory techniques.
  • Experience with the production of single-cell and/ or ancient genetic data.
  • Experience with statistical data analysis.

Terms of employment
The average weekly working hours are 37 hours per week.
The position is a fixed-term position limited to a period of four years. The starting date is 1 January 2025 or as soon as possible thereafter.
Employment will be in accordance with the provisions of the collective agreement between the Danish Ministry of Taxation and AC (the Danish Confederation of Professional Associations) as Academic Research Staff.
The monthly salary will be based on the number of years of work experience (seniority) with the possibility to negotiate a salary supplement based on prior experiences and qualifications. The employer will pay an additional 17.1 % to your pension fund.

Further information
For further information regarding the position, please contact Ana Prohaska; 
anaprohaska@sund.ku.dk

 

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Medical Science Liaison
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CONTEXT, MAIN ACTIVITIES AND RESPONSIBILITIES
● Works closely with the Medical department to establish a medical foot-print for Laboratori Guidotti.
● Establishes, develops and manages collaborative relationships with key medical experts and opinion leaders of Italy related to any current and future disease areas relevant for Laboratory Guidotti (diabetes area in particular).
● Drives disease awareness in providing external medical disease education and – when appropriate- setting up local scientific programs, such as symposia, regional advisory boards, or scientific meetings in accordance with the respective Laboratori Guidotti disease plans.
● Coordinates and pro-actively contributes to all pre-launch and life cycle activities any pipeline products.
● Provides medical support and medical information on unsolicited HCP requests related to any Laboratori Guidotti in-line and pipe-line products in accordance with the relevant Menarini processes and the Italian regulations.
● Is an active member of scientific and educational interactions with therapeutic specialists on diagnostic and clinically relevant aspects of any therapeutic areas in which Laboratori Guidotti is active.
● Locally facilitates any patient access programs (EAP) to address high unmet medical needs.
● Collects competitive intelligence and market insights within the region on diagnostic methods and treatment paradigms of any therapeutic areas relevant for Laboratori Guidotti.
● Pro-actively supports internal medical knowledge (reps) on any relevant disease and product related aspects.
● Manages/supports local aspects of investigator-initiated trials or other research projects; on request through Global Clinical Operations, supports delivery of patient enrolment in Laboratori Guidotti clinical trials.
● Ensures legal excellence and compliance in all medical activities as per Laboratori Guidotti SOPs and local regulations List the core areas of responsibility.

JOB REQUIREMENTS
● A strong bio-science education background.
● Doctorate degree (MD, PhD, PharmD) is preferred.
● Ability to understand and effectively communicate scientific and medical information to both internal and a variety of external customers.
● Mobile, willing to travel extensively in the region.
● Strong communication skills, open style & pro-active.
● Fluent English and Italian is essential.

BASED: Pisa

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Corsi di formazione per scegliere la Carriera giusta per te
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Formazionenelfarmaceutico.com è la prima piattaforma e-learning nata in Italia, per fornire a laureandi, neolaureati, giovani professionisti e professionisti del settore che vogliono studiare, aggiornarsi ed essere al passo con le novità del mondo della ricerca clinica.
La piattaforma conta ad oggi più di 15.000 iscritti, oltre 250 corsi ed innumerevoli trainer con una formazione completa al tuo servizio.

Il panorama del mondo Pharma è in continua evoluzione, ed è sempre pronto a fornire nuovi spunti di crescita professionale. A partire da questo articolo potrai scegliere il ruolo giusto per te, troverai elencate diverse figure, le loro competenze e i loro percorsi formativi.


Chi è il Clinical Research Associate?

Generalmente chiamato CRA, o Clinical Monitor, è colui che si occupa della valutazione, dell’andamento e del monitoraggio dello studio presso i centri clinici, per garantire che la ricerca venga effettuata in ottemperanza al protocollo, alle Procedure Operative Standard, alle disposizioni normative vigenti e alle Good Clinical Practice (GCP).
Suo compito è quindi selezionare i centri clinici, sottomettere la documentazione al Comitato Etico e alle autorità competenti, svolgere i training iniziali agli sperimentatori e gestire le visite di monitoraggio al centro.
Per poter svolgere il proprio ruolo, il futuro CRA dovrà essere in possesso di una laurea magistrale in materie scientifiche, avere una buona conoscenza delle GCP e della metodologia della ricerca clinica con almeno 40 ore di formazione teorica, effettuare almeno 20 giorni in affiancamento con un CRA esperto per capire al meglio come funziona il monitoraggio degli studi presso i centri sperimentali. Sono richieste competenze organizzative e di gestione delle attività, ottime capacità comunicative in lingua italiana e inglese.
Questo ruolo prevede la possibilità di viaggiare per buona parte del tempo, ma anche di svolgere parte della propria attività direttamente in sede, o dalla propria casa.


Chi è il Clinical Research Coordinator?

Questa figura è anche conosciuta come study coordinator o in abbreviazione come CRC. È il coordinatore della sperimentazione clinica. Funge da punto di raccordo tra tutti i professionisti del team di ricerca, tra cui Principal Investigator (PI), Comitato Etico, Sponsor, Farmacia Ospedaliera ecc. Supporta il PI nella conduzione dello studio clinico, assicura la qualità del dato proveniente dalle sperimentazioni cliniche e gestisce in loco le visite di monitoraggio da parte degli sponsor.
Questo ruolo viene svolto all’interno delle aziende ospedaliere o degli IRCCS. È richiesta una laurea in materie scientifiche, conoscenze in ambito GCP, capacità organizzative e di time management. Inoltre, ha buone capacità comunicative.
Il suo lavoro si svolge in buona parte in presenza.

Entriamo nel mondo della qualità. Chi è l’Auditor?

È il professionista che in accordo al D.M. del 15/11/2011 può condurre audit. Gli audit sono valutazioni indipendenti volte ad analizzare con attenzione tutto ciò che concerne uno studio clinico, dalla documentazione, alle strutture, ai laboratori interessati. Per poter svolgere questo ruolo è necessario il possesso della laurea specialistica in materie scientifiche, almeno 60 ore di formazione teorica, almeno 20 giorni di auditing in affiancamento ad un auditor esperto e almeno 4 mesi di attività negli ambiti di quality assurance e quality control.
E’ richiesta attenzione ai dettagli, ottime capacità relazionali e analitiche e il saper lavorare in team.
Il lavoro sarà svolto nella maggior parte del tempo da remoto, fatta eccezione per le trasferte necessarie per l’esecuzione di audit da svolgere presso il centro selezionato.


Chi è il Quality Assurance (QA)?

È il responsabile del sistema di gestione della qualità della ricerca clinica, che garantisce la conformità delle attività aziendali e degli studi clinici in accordo alle normative vigenti. Assicura che il sistema di qualità della ricerca clinica sia efficace affinchè l'integrità e l'affidabilità dei dati, e la salute e il benessere dei soggetti partecipanti siano tutelati. Si occupa di controllare, redigere e modificare le SOP, gestendo le non conformità e monitorando le Azioni Correttive e le Azioni Preventive (in inglese, CAPA).

Ma come si diventa QA?

È richiesta una laurea specialistica non necessariamente in materie scientifiche, almeno un anno di attività pratica documentata in materia e almeno 15 giorni di formazione teorica nel settore della qualità. Il profilo ideale è diplomatico, ha ottime capacità di comunicazione, di coordinamento delle attività ed è flessibile.
Il quality assurance svolge il proprio ruolo in ufficio.

Chi è lo Start Up Specialist?

È colui che è responsabile del coordinamento delle attività che riguardano la sottomissione di uno studio clinico, in accordo con le GCP, le SOP e le normative vigenti. Si relaziona con il team della Contract Research Organization, con l’azienda ospedaliera e con lo Sponsor. Si occupa di eseguire gli studi di fattibilità, selezionare i centri, preparare la documentazione necessaria per lo studio clinico. La sua preparazione iniziale, in quanto figura entry level, è molto basica. Non è richiesta la laurea in materie scientifiche, si richiede una buona
conoscenza della lingua inglese e buone abilità informatiche. Inoltre, è richiesta una buona capacità di saper lavorare in gruppo, attenzione ai dettagli e di time management.
Spesso questo specialista è definito in house, poichè svolge il suo lavoro direttamente in ufficio.

Chi è il Medical Science Liaison (MSL)?

È il consulente altamente qualificato del mondo aziendale farmaceutico. Se si ha già esperienza nel mondo farmaceutico o nel mondo della ricerca clinica, si potrebbe rivestire questo ruolo. Diventando il punto di riferimento delle figure mediche, si avranno contatti con i KPI (Key Opinion Leaders), i clinici e gli sperimentatori, intercettando le loro esigenze, ma allo stesso tempo comunicando le novità e le caratteristiche dei prodotti farmaceutici dell’azienda per cui si lavora. Comprendendo il mercato farmaceutico e le loro dinamiche, si sapranno cogliere le nuove opportunità di sviluppo scientifico e presentarle all’azienda. Si diventerà cultori della materia, partecipando a numerosi congressi e pubblicando articoli scientifici sulle più importanti riviste mediche.

Ma come si diventa MSL?

Ad una buona determinazione, si affianca un solido background scientifico, una pregressa esperienza nella ricerca scientifica (meglio se clinica) e conoscenza del sistema sanitario del Paese per cui si lavora. In questo caso, circa il 25-75% del proprio tempo lavorativo, l’MSL lo trascorre viaggiando.

Chi è il Pharmacovigilance Specialist in area pre-marketing?

È la figura aziendale che si occupa di farmacovigilanza, disciplina volta alla sorveglianza e alla gestione degli eventi avversi dei farmaci. Il suo è un ruolo chiave nell'interazione con altre figure professionali come medici e staff del centro sperimentale, Sponsor e autorità regolatorie. Il Pharmacovigilance Specialist, infatti, monitora i dati di safety provenienti dagli studi clinici, comunicando le reazioni gravi alle autorità regolatorie e contribuendo alla valutazione del rapporto rischio/beneficio dei farmaci sperimentali.

Ma come si diventa Pharmacovigilance Specialist?
È consigliato possedere un solido background in farmacologia, conoscere la normativa vigente e/o avere esperienza pregressa nell’ambito, avere buone capacità di analisi e di redazione di report. Il lavoro può essere svolto in modalità remota o ibrida ed è fondamentale la conoscenza della lingua inglese.


Il punto che accomuna tutti i ruoli della ricerca clinica, è la formazione. Conoscere le GCP, le normative e tutto quello che ruota attorno a questo mondo è fondamentale per iniziare e fare la differenza.
Il dipartimento di training service di ClinOpsHub si occupa proprio di questo, partendo da corsi come Missione CRA che forniscono una preparazione da entry level al Missione QA, Missione MSL e molto altro ancora per specializzarsi.

Per saperne di più partecipa al webinar del 17 ottobre: Il ruolo del CRA nella Contract Research Organization

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Per maggiori informazioni: www.FormazioneNelFarmaceutico.com

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