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Bio Pharma Day 2024
On-line from March 13th 
+ Event in Milan on March 26th 


WHAT IS BIO PHARMA DAY?

Bio Pharma Day is the exclusive career day organized by Jobadvisor entirely dedicated to job and training opportunities in the pharma and biotech industry.

Bio Pharma Day is addressed to students, graduates and young professionals with biomedical, biotechnological, chemical, pharmaceutical, medical and healthcare, medical and biomedical engineering background coming from the main Italian universities.

Bio Pharma Day in 2024 will be structured in two virtual fairs (on March and November) 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


DISCOVER THE PAST EDITION
 

WEBINAR


Here the webinars' calendar. Stay tuned!
You can attend to the live streaming session or you can watch the video recording.

COMPANIES

These are the companies that you can meet at Bio Pharma Day:
VIRTUAL Job Fair from March 13th (green label)
Event in MILAN on March 26th at Superstudio Events, via Tortona 27 (yellow label)

More companies will be added soon!

OPPORTUNITIES

Here you will find the list of opportunities you can apply for.
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. 

TO APPLY YOU HAVE TO WAIT THE START OF THE VIRTUAL FAIR ON MARCH 13th

 

 

 

Company
Title

Impiegato tecnico farmaceutico
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Manpower, filiale di Latina, ricerca per azienda farmaceutica del territorio di Latina un IMPIEGATO/A TECNICO da inserire all'interno dei loro uffici per affiancare nell'operatività la direzione di stabilimento.

Requisiti:
- Sei in possesso di un diploma tecnico o una laurea (anche triennale) in Ingegneria, preferibilmente in ambito chimico, meccanico o gestionale;
- Hai un'ottima conoscenza del pacchetto Office, specialmente Excel per la scrittura di report, planning, scheduling;
- Hai competenze nell'utilizzo di gestionali aziendali;
- Hai maturato anche una minima esperienza all'interno di contesti produttivi in mansioni simili;
- Hai una buona conoscenza della lingua inglese (B2).

Cosa offriamo:
- Contratto a tempo determinato iniziale volto all'inserimento;
- Contratto collettivo nazionale Chimico con tredici mensilità e Ral iniziale di circa 23K lorde annue.

Se sei un neo laureato motivato a formarsi e che desidera inserirsi in un contesto industriale del settore pharma questa è l'opportunità giusta per te!
Inviaci la tua candidatura candidandoti all'annuncio e aggiornando il tuo curriculum vitae. Non vediamo l'ora di iniziare a collaborare con te!

Sede: Latina

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Stage Marketing – Milano
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Sede: Milano
Modalità: ibrida
Tipologia di contratto: STAGE curriculare o extracurriculare di 6 mesi, con possibilità di proroga. È previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per la propria sede di Milano una risorsa da inserire in stage all'interno del dipartimento Marketing della Business Unit Vaccini, in area pediatrica. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:
♦ Supporto nell’implementazione delle strategie di marketing dell’area pediatrica
♦ Supporto nello sviluppo di materiali promozionali rivolti alla classe medica e cittadino, sia cartacei che digitali, in linea con le strategie aziendali
♦ Supporto nello sviluppo dei progetti digital
♦ Supporto nella fase di Execution di progetti di customer engagement;
♦ Supporto nell’organizzazione di eventi standalone/congressi
♦ Partecipazione a conference call e meeting aziendali;
♦ Elaborazione di file Excel e presentazioni Power Point.

Requisiti:
♦ Laurea in materie scientifiche (farmacia, CTF, biologia e affini);
♦ Master in Marketing o Management farmaceutico
♦ Buona conoscenza della lingua inglese (livello B2);
♦ Atteggiamento proattivo, buone capacità comunicative e di lavoro in team.

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Stage Medical Affairs – Milano (area Respiratoria e Gastroenterologica)
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Sede: Milano
Modalità: ibrida
Tipologia di contratto: STAGE curriculare o extracurriculare di 6 mesi, con possibilità di proroga. È previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per la propria sede di Milano una risorsa da inserire in stage all'interno del dipartimento Medical Affairs della Unit Specialty Care, in area Respiratoria e Gastroenterologica. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:
♦ Affiancamento e supporto nella definizione e lo sviluppo dei contenuti e dei materiali necessari all’attività del team di direzione medica;
♦ Gestione in sinergia con il tutor di alcune attività e/o processi all’interno del piano medico con un focus su progetti scientifici, anche implementati dalla Direzione Medica Global;
♦ Produzione in affiancamento al tutor di alerting di letteratura e preparazione newsletters periodiche;
♦ Manutenzione file di tracciabilità delle attività (sia richieste di letteratura che informazioni);
♦ Supporto alle attività di revisione e aggiornamento documentazione scientifica;
♦ Supporto all’ideazione e alla creazione di nuovi strumenti per aggiornamento scientifico continuo del personale interno e per la valorizzazione del Medical Services all’interno e all’esterno dell’azienda;
♦ Partecipazione a conference call e meeting aziendali;
♦ Elaborazione di file Excel e presentazioni Power Point.

Requisiti:
♦ Laurea in materie scientifiche (farmacia, CTF, biologia e affini);
♦ Buona conoscenza di Excel e PowerPoint;
♦ Ottima conoscenza della lingua inglese (livello C1);
♦ Atteggiamento proattivo, buone capacità comunicative e di lavoro in team.

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Maintenance Engineer
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Riportando al Responsabile dei Servizi di Ingegneria di Stabilimento si occupa delle seguenti attività:
1. gestione della manutenzione programmata e straordinaria
2. coordinamento del personale di manutenzione, sia interno che esterno
3. gestione delle attività di qualifica e calibrazione delle apparecchiature e strumentazione critica

In particolare egli/ella ha il principale compito di gestire al meglio il processo manutentivo assicurando la disponibilità e la piena efficienza degli equipment, impianti e delle strutture delle aree GxP, conformemente alle procedure aziendali vigenti. Sviluppa piani di miglioramento volti a snellire e rendere più efficienti le procedure di manutenzione.

Svolge indagini tecniche approfondite in caso di guasti su impianti, utilities e macchine di processo, al fine di individuarne le cause ed implementare specifiche azioni correttive.
Ha il compito di garantire la conformità delle apparecchiature, macchine di processo e impianti alle norme vigenti.

Supervisiona l’operato delle ditte esterne di manutenzione (per le aree GxP e non) attraverso il controllo delle presenze giornaliere, della corretta esecuzione dei lavori e la successiva gestione della contabilità.

Gestisce il flusso degli acquisti delle parti di ricambio per impianti ed utilities, garantendo il corretto approvvigionamento dei materiali.
Redige, per le attività di sua competenza, i permessi di esecuzione lavori.

Profilo:
La ricerca è rivolta a un giovane ingegnere, preferibilmente specializzato in ambito chimico (alternativamente in ambito meccanico), che abbia maturato un’esperienza di almeno 2 anni in contesti produttivi preferibilmente del settore chimico-farmaceutico (o in alternativa del chimico, plastico, alimentare, cosmetico, petrolifero) come assistente nell’area manutenzione e/o ingegneria.

Determinato, propositivo e fortemente motivato alla propria attività lavorativa, dovrà possedere una capacità comunicativa che gli consenta di relazionarsi in modo positivo ai diversi livelli aziendali.
Completano il profilo una buona conoscenza della lingua inglese e la disponibilità a sporadiche trasferte. 

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Project Engineer
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MAIN ACTIVITIES AND RESPONSIBILITIES
• Gestirà all’interno dello stabilimento progetti di modifica di impianti e/o infrastrutture (attività di project management).
• Garantirà il rispetto delle tempistiche, del budget e dei vincoli di sicurezza e ambientali durante tutte le fasi dell’elaborazione e realizzazione dei progetti a lui assegnati.
• Supervisionerà la fase di construction, coordinandosi con le ditte appaltatrici e interfacciandosi con consulenti esterni e supporterà le fasi di commissioning.
• Supporterà attività di qualifica (URS, DQ, IQ, OQ) in ambito cGMP.
• Collaborerà con le altre funzioni di sito (QA/QC, Produzione, HSE, R&D).
• Supporto attività di verifiche periodiche da parte enti pubblici per normative PED/Atex/F-GAS/Inail
• Supporto attività e progetti di miglioramento nell’ambito della certificazione energetica ISO 50001.

JOB REQUIREMENTS

Competenze tecniche e soft skill:
• Laurea in ingegneria (chimica o industriale) con esperienza preferenziale nel settore chimico/farmaceutico.
• Preferenziale conoscenza direttiva Atex 2014/34/EU e PED 2014/68/EU, D.M. 239 del 2004
• Buona conoscenza dell’impiantistica industriale e consapevolezza relativamente ai vincoli tecnici in ambito HSE e processo.
• Capacità di lavorare sia in team che in autonomia.
• Buone capacità di pianificazione e di organizzazione, con l’utilizzo di strumenti tipici del project management (sviluppo Gantt Chart, ecc..).
• Spirito di proattività e multitasking.

Competenze tecniche e soft skill “Nice to Have”:
• Buona conoscenza inglese.
• Conoscenza Autocad, SAP.
• Flessibilità nello svolgere diverse tipologie di lavoro afferenti al ruolo.

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Upstream Process Scientist
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Are you a highly motivated and experienced Upstream Process Scientist? Would you like to play a key role in providing scientific leadership to support both clinical and commercial cell culture programs?

Then we hope you will join our rapidly expanding Process Science Team!

Your New Role
You will be engaged with customers around the world ensuring a smooth tech transfer of new cell culture processes to our manufacturing facility. You will also provide scientific support in various projects and ongoing productions.

Your main tasks
- Participate in tech transfer activities for new programs both internally and externally (with customers).
- Collaborating closely with our Upstream Manufacturing Department to support all running programs.
- Interpretation of manufacturing data and/or laboratory data to aid in root cause investigation and process impact assessments.
- Writing documentation for internal and external use, such as manufacturing campaign summary reports, PPQ protocols/reports, and impact assessments.

Your Skills, Talent & Knowledge
- Bachelor’s or master’s degree in a relevant field such as bioprocess technology, biotechnology, chemical engineering or related field.
- Preferably 5+ years of industry experience in upstream cell culture or biologics manufacturing.
- Knowledge or experience with GMP production and behaviour Flexible, hard-working attitude, and a willingness to take on responsibility.
- Self-motivating and capable of working both independently and in a team environment. Strong verbal and written communication skills in English.

As a person you are
You are curious of nature, you meet and greet people with a smile and have a can-do attitude. You work with a humility and respect for the people around you. You are independent, pragmatic and able to prioritize tasks to meet defined timelines. You work structured with a quality mind-set and enjoy working independently and proactive in a dynamic entrepreneurial environment.

Your New Team
The Process Science team, which consist of 17 dedicated and enthusiastic professionals, acts as leads in process technology transfers, are the Subject Matter Experts for running processes, responsible for scale up/scale down of processes as well as other projects.

The Process Science team is a dynamic environment, and you will have the opportunity to work with highly skilled and trustworthy colleagues and make a real impact on the company's success. Cross-functional collaboration throughout the entire organization is an important part of our everyday work. The department continuously strives to identify opportunities to improve systems and practices and provides direction to the manufacturing organization.

The work environment is international and informal. We keep a high pace and focus on a vital work life balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Location: Hillerød, Denmark

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Operations Internship - Pharma
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Eli Lilly Italia, per lo stabilimento di Sesto Fiorentino, è alla ricerca di una risorsa da inserire in un interessante percorso di stage extra-curriculare come Operations Intern - Pharma.

Riportando direttamente al Sr. Manager dell'area, la risorsa sarà parte di un ambiente dinamico e collaborativo, svolgendo attività di supporto alla produzione, come analisi e ottimizzazione del processo di Filling (riempimento cartucce). Il focus primario sarà sullo sviluppo di un sistema di pianificazione efficiente, l'identificazione di possibili ottimizzazioni e la definizione di parametri operativi che riflettano l'efficienza del processo.

Il progetto si svolgerà principalmente in ambiente produttivo, permettendo alla risorsa di interfacciarsi con diverse funzioni, i supervisori di produzione, la funzione Quality e il personale di campo.

Attività Da Svolgere:

  • Raccogliere dati direttamente sul campo, osservando e interagendo con il processo di riempimento cartucce;

  • Analizzare i dati raccolti per identificare aree di miglioramento nel processo;

  • Utilizzare strumenti 5S lean per ottimizzare la disposizione degli strumenti e delle attrezzature, migliorando l'efficienza operativa;

  • Finalizzare e organizzare le metriche relative al processo produttivo;

  • Contribuire alla revisione e all'aggiornamento delle Standard Operating Procedures (SOP), assicurando la coerenza tra le pratiche di produzione e le procedure documentate.

Requisiti Richiesti:

  • Laurea Magistrale in Ingegneria, Chimica, CTF, Biologia

  • Ottima conoscenza della lingua inglese

  • Proattività e capacità di organizzazione

  • Ottime abilità cominicative e flessibilità di approccio

  • Attitudine al Teamworking

Previsto inserimento in stage con rimborso spese pari a 1100€ al mese con accesso gratuito alla mensa e bar aziendali.

 

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Process Engineer
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Eli Lilly is looking for a Process Engineer to join our mission to make medicine with safety first and quality always, bringing passion, technical expertise and his/her whole self to work. The Production Organization in Sesto Site is composed of two parenteral departments – Insulin module and PFS (Prefilled Syringes) module –, a Packaging & Device module and the Utilities department. The strategic organization of the site is based on cross-functional teams, along different levels, in order to guarantee robust performance and reliability of production equipment, pursuing operational excellence

The Process Engineer is part of the Process Team – composed by one or more representatives for each function: engineering, technical service, quality, operation and process automation; he/she is the primary point of contact for everyday issues and every other aspect related to the system under his/her responsibility and for any escalation from the floor (operation, maintenance and in process quality control). As a part of the site Engineering organization, he/she reports directly to the Engineering Senior Manager of the module and is the technical contact inside the Process Team for all the technical aspects related to the process and equipment, from a reliability and maintenance point of view, in order to reach the production plan.


Main responsibilities of the role:

  • Technical responsibility and deep knowledge of the process and its parts (including documents)
  • Ensure systems top efficiency and the production plan compliance (leveraging on the systems availability, quality and performance); monitor the cycles and equipment data and the area metrics (OEE, alarms, stoppages, ect.)
  • Develop, integrate and review SOPs and Technical Assessments on the system under his/her responsibility, in order to guarantee the operation standardization and knowledge transfer across the area population
  • Investigate any production problems with quality or safety impact (also called deviations)
  • Manage trouble shooting and problem solving of normally complex issues and perform the technical coaching onto problems
  • Work with the Maintenance Team to ensure that all the preventive or corrective activities are correctly executed and managed before the due date, in safety and quality and the overall maintenance programs are adequately implemented
  • Plan Shut Down or production stoppage activities working with the Maintenance Manager; on field presence during shut Down period in order to guarantee planning execution
  • Propose and manage continuous improvement initiatives (maintenance policies, Return To Service; equipment reliability, communication processes, data analysis, safety practices)
  • Analyze all the relevant KPI (OEE, maintenance Work Order execution, HSE, Quality and Data Integrity) to evaluate improvement projects
  • Identify anomalies and issues happening in the systems and work with the Team to solve them and avoid recurrencies
  • Collaborate with Technical Team and Responsible Engineer in the execution of tests and modification protocols
  • Interact with internal stakeholder to understand their needs and propose an adequate plan of action
  • Interface with external contractors in case of needs or to involve them on projects when required


Minimum requirements:

  • Master's Degree in Engineering (Mechanical, Chemical)
  • Attention to HSE, Quality and Data Integrity aspects
  • English fluency (minimum B2 level)
  • At least 1-2 years of experience in engineering, maintenance or other technical role, preferably in a Pharma Company.


Additional skills/preferences:

  • Attitude to Teamworking and Problem Solving
  • Capability to work under pressure
  • Multitasking attitude
  • Proficiency in Microsoft Office
  • Knowledge on data analytics and basic statistical method
  • Knowledge of maintenance basics and its metrics
  • Knowledge of safety regulation related to machinery (Machinery Directive, PED, etc..)

 

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QA Supplier Internship
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Eli Lilly Italia, per lo stabilimento di Sesto Fiorentino, è alla ricerca di una risorsa da inserire in un interessante percorso di stage extra-curriculare nella funzione Supplier Quality Management.

Riportando direttamente al responsabile di area, la risorsa si occuperà di supportare lo sviluppo dei Quality Agreement dei Service Provider di manutenzione e dei Service Provider che gesticono dati per conto di Lilly.

Il/La tirocinante avrà come riferimento il responsabile del Reparto di Supplier Quality management ed interagirà con i referenti Lilly e dei Service per finalizzare i Quality Agreement e documenti di Suporto (SMRD).

Il progetto è finalizzato a colmare un gap in questa categoria di Quality Agreement e prevede l’interazione con le funzioni di fabbrica che gestiscono direttamente il fornitore: Manutenzione, Laboratori, Utilities, Information Technology e Procurement.

 

Principali attività:

  • Organizzazione del lavoro e definizione della timeline di progetto

  • Identificazione dei Service Provider in scopo del progetto e relativi key contact Lilly

  • Verifica della presenza dei documenti di Service Support Agreement e coordinamento della tempistica per la preparazione, nel caso in cui non siano presenti

  • Contatto con i fornitori (Service Provider) per condividere i contenuti degli agreement oggetto di revisione

  • Monitoraggio del flusso approvativo degli agreement

  • Supporto del reparto nella gestione dei Service Providers

  • Utilizzo dei sistemi TrackWise 138, per documentare la classificazione del rischio, e Veeva, per le approvazioni degli agreement

 

Requisiti richiesti:

  • Laurea Magistrale in discipline scientifiche (Ingegneria, Chimica, CTF, Biotecnologie)

  • Ottima conoscenza della lingua inglese (B2/C1)

  • Proattività e capacità di organizzazione

  • Ottime abilità cominicative e flessibilità di approccio.

  • Attitudine al Teamworking

 

Previsto inserimento in stage con rimborso spese pari a 1100€ al mese con accesso gratuito alla mensa e bar aziendali.

 

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R&D Cosmetic and Nutraceutical Formulator
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Siamo alla ricerca di un formulatore da inserire nel Team R&D per la messa a punto e lo sviluppo di dermocosmetici e integratori alimentari. La risorsa dovrà occuparsi della definizione di formule di cosmetici in forma liquida e di prove galeniche di laboratorio per la messa a punto delle caratteristiche tecnico-sensoriali del prodotto in sviluppo.

Tipologia di contratto: Contratto di apprendistato oppure stage semestrale full time con rimborso spese e concrete prospettive di continuità, in base all’esperienza del candidato.

Modalità: in presenza

Sede: HQ – Mereto di Tomba (UD) / Monselice (PD)

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Master Quality, Esperti e Manager in Sistemi di Gestione Aziendale
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Master Quality, Esperti e Manager in Sistemi di Gestione Aziendale
Qualità, Sicurezza, Ambiente, Energia, Agroalimentare |
85ª Edizione




Date, modalità di frequenza e partecipazione:

La prossima Edizione inizierà il 06/05/2024, l’Edizione successiva inizierà ad ottobre 2024 (poi si prevedono nuove Edizioni a febbraio, maggio, ottobre 2025).

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

Descrizione:
Il Master Quality rappresenta il più longevo, aggiornato e performante Master su i Sistemi di Gestione Integrati, oggi arricchito di nuove Tematiche emergenti e di nuove Competenze professionali in uscita: dall’ENERGY e la figura del “green job” all’Autorizzazione Unica Ambientale; dalla Responsabilità amministrativa delle società alla Gestione dei Rifiuti, come anche il Modulo Green sulla Sicurezza Alimentare.

Il Master si compone di una prima fase d’aula di 2 mesi, da poter svolgere in modalità E-Learning oppure in presenza a Roma o Milano, ed una successiva fase di stage garantito contrattualmente di 6 mesi da poter svolgere nelle oltre 750 Aziende Partner di Uninform Group, tra le più importanti aziende italiane in tutti i settori strategici dell’economia (chimico, farmaceutico, biomedico, consulenziale, aerospaziale, alimentare, ecc.).

Le 84 Edizioni già svolte hanno permesso di formare oltre 3.500 candidati che hanno trovato una collocazione in aziende, società di consulenza, multinazionali, Pubblica Amministrazione.

Il Master Quality è l’unico Master in Sistemi di Gestione Aziendale ad essere qualificato CEPAS (Organismo di Certificazione delle Professionalità e della Formazione), inoltre rilascia 15 Attestazioni Professionali (Qualità, Sicurezza, Ambiente, Energia, Agroalimentare, Privacy, Responsabilità Amministrativa e Sociale d’impresa) e tra queste anche gli attestati come Lead Auditor Qualificati in Qualità, Sicurezza, Ambiente, Energia, Agroalimentare.

Per iscriversi:
Per iscriversi al Master è necessario svolgere la selezione di accesso al Master 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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QC Biological Laboratory Technician
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Eli Lilly Italia, per lo stabilimento di Sesto Fiorentino, è alla ricerca di risorse da inserire in qualità di QC Biological Laboratory Technician.

Le principali responsabilità del ruolo sono legate all’esecuzione dei seguenti test di laboratorio in conformità con le GMP e le SOP aziendali:

  • Test biologici su eccipienti e API

  • Test biologici in-process e su prodotto semi-finito

  • Test di sterilità

  • Dosaggio delle endotossine batteriche

  • Conta microbica totale

  • Identificazioni microbiche

  • Bioassay

  • Bioburden Testing

  • Analisi conta particellare (HIAC ROYCO)

  • Campionamento ambientale e clean utilities

Ulteriori attività e responsabilità del ruolo:

  • Gestione dati e analisi attraverso sistemi informatici (CAPA,TrackWise, GMARS, SMARTLAB, DarwinLIMS)

  • Scrittura di procedure di laboratorio

  • Scrittura protocolli di convalida e report

  • Lettura terreni e monitoraggio ambientale

  • Effettuare campionamenti delle Clean Utilities

  • Ispezione media fill

  • Partecipare alla pulizia e al buon mantenimento del laboratorio

Requisiti minimi richiesti:

  • Laurea Magistrale in Biologia o Biotecnologie

  • Esperienza pregressa in laboratorio biologico/microbiologico

  • Buona conoscenza della lingua inglese (livello B2)

Si richiede la disponibilità a lavorare su turni mattina/pomeriggio.

 

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QC Analyst
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Principali attività:
• Esegue analisi chimiche e microbiologiche in accordo alla documentazione approvata (procedure, metodiche)
• Utilizza tecniche analitiche quali: GC, HPLC, UV, FTIR
• Utilizza supporti informatici
• Sviluppa nuovi metodi analitici
• Prepara protocolli di convalida delle metodiche analitiche
• Supporta il Responsabile QC nella revisione delle procedure
• Esegue attività di campionamento
• Rispetta le procedure di laboratorio e contribuisce al loro miglioramento.

Requisiti:
• Laurea in discipline scientifiche (Chimica, CTF, Farmacia, Chimica Industriale)
• Conoscenza delle normative e linee guida che regolano l'ambito farmaceutico (GMP, GLP, ICH)
• Ottima conoscenza/utilizzo di software di calcolo e di scrittura (MS Word, MS Excel)
• Conoscenza delle problematiche relative alla Data Integrity
• Ottima conoscenza della lingua inglese.

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Project Quality Assurance Specialist
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Do you want to have an extensive influence and add your footprint on our future Drug Product Facility at FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD)? Do you have experience with Fill Finish area and construction projects?

We are looking for a QA professional to join our (ongoing) Drug Product (DP) manufacturing project. In the first part of the journey, you will manage Project Quality Assurance (PQA) activities taking up the PQA Lead role to support the implementation of a new DP facility. When the project is implemented, you will transition to the daily DP QA operations team.

About the Department and Project Team
The DP QA Operations team is currently based under the Project Quality Assurance organization. Together, we shape the QA mindset for the future and the work environment is informal and with a good sense of humor, while keeping a high pace. Within the DP QA team there are QA ops personnel that supports the “Operational Readiness” part of DP project and there are project QA’s focusing on facility and equipment implementation. As a team, We are deeply committed and takes great pride in working with all types and levels of stakeholders.

About the Role
As the DP project QA lead, you will manage the project QA team that consists of two skilled QA specialists and 1-2 QA consultant supporting the commissioning, qualification, and validation activities of the DP project in Hillerød. You will work close together with the other project leads from other disciplines such as engineering, construction, CQV and automation. You will also be the responsible QA on one of the major process equipment packages such as the isolator-based filling line. In the DP project there is a respectful and safe atmosphere where open and honest communication and high level of agility is a reality.

After facility/equipment commissioning and IQ/OQ/PQ you will continue working in the team who will have Quality Oversight of the DP facility operations and all other Quality related activities.

Job Responsibilities
Your primary tasks while working as Project QA Lead will be:
- Lead up the DP Project QA (PQA) through SAT, IQ, OQ and PQ activities.
- Be very visible in the project and DP organization and therefore have strong stakeholder management skills.
- Create, approve and maintain quality plans and procedures.
- Continuous align with CQV Project Lead on CQV process to be utilized on the project with consideration given to ASTM E250 and leveraging from FAT into IOQ.
- Review and approve updates to Validation Project Plans covering Process-and support equipment IT/Automation, clean utilities and facility.
- Lead the reporting of Vendor Performance Evaluations (initial assessments and approvals are completed)
- Aligning with the DP Project Manager and project leads on requirements, maintain and manage PQA team for the duration of the project, both planning and forecast costing for the team.
- Ensure PQA pre-approval on all direct impact documentation to fully align with the project’s leveraging philosophy.
- Review and approve SAT/IQ/OQ and PQ for major process equipment e.g. filling line or automatic inspection machine
- QA involvement in clean room area readiness and qualification - Oversight over project change management planning and execution
- Involvement in internal Mock-up audits to prepare for GMP inspection.

Qualifications
- You hold a Master of Science within Pharmacy, Biotechnology, Biology, Technical Engineering or similar.
- You have +5 years of QA for engineering/validation experience including experience with design and construction projects, preferable with fill-finish equipment and facility.
- Strong leadership skills with knowledge on how to set the direction for the project regarding quality.
- Working knowledge of principles, concepts, and practices of ASTM E2500/Leveraging Verification process.
- Deep cGMP knowledge.
- Fluent in English both verbally and in writing.

Personal skills
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Self-starting and have a flexible, dynamic approach to work.
- Attention to details yet keeping the overall picture of the project.
- You communicate in a proactive and solution-focused manner and function well in a cross-functional team environment.
- As a person you enjoy a fast paced and changing environment.
- You are a team player who is motivated by working in a dynamic environment with a strong focus on providing support to both colleagues and stakeholders.

Location: Hillerød, Denmark

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Farmacista Collaboratore
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Sede: Milano
Modalità: Full-time
Tipologia contratto: retribuzione commisurata all'esperienza e professionalità

Cerchiamo Farmacista Collaboratore da inserire all’interno delle nostre Farmacie di Milano.
Il Farmacista Boots, in diretto riporto al Direttore di Farmacia, ha la responsabilità della cura e soddisfazione dei nostri pazienti-clienti.

Grazie alla stretta collaborazione con il direttore e i colleghi avrai la possibilità di sviluppare a 360° le tue competenze in ambito consulenziale, gestionale e legislativo. Inoltre, avrai una formazione costante che si articola nei due grandi ambiti della farmacia: scientifica e prodotto.

Cosa offriamo:
♦ Percorsi di crescita interna
♦ Sistema incentivante
♦ Ambiente dinamico e stimolante

Requisiti:
♦ Laurea in Farmacia o CTF (anche in corso)
♦ Iscrizione all'albo

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Quality Assurance Officer
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Siamo alla ricerca di un Quality Assurance Officer da inserire all’interno del team QA e si occuperà della redazione, emissione e aggiornamento e supporto documentale al SGQ; supporto nello svolgimento di Audit interni e verso fornitori e redazione di Dossier Clienti e di Capitolati Tecnici Clienti.

Tipologia di contratto: Stage semestrale full time con rimborso spese e concrete prospettive di continuità, in base all’esperienza del candidato.

Modalità: in presenza

Sede: HQ – Mereto di Tomba (UD) / Gallarate (VA)

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Stage Production– Scoppito
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Sede: Scoppito (L’Aquila) 
Modalità: presenza
Tipologia di contratto: STAGE extracurriculare di 6 mesi, con possibilità di proroga. È previsto un rimborso spese e accesso gratuito alla mensa aziendale.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per il proprio sito produttivo di Scoppito (L’Aquila) una risorsa da inserire in stage all'interno del reparto di Produzione. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

La persona che verrà inserita sarà formata e di supporto a diverse attività:
♦ Formazione sulle GMP di produzione e sulle procedure di manufacturing e Soft Gel Capsule;
♦ Aggiornamento e supporto per Visual Management, 5S, one point lesson;
♦ Analisi della produttività;
♦ Supporto ai piani training del personale in entrata;
♦ Supporto alla preparazione di presentazioni;
♦ Supporto alla stesura di procedure di reparto;
♦ Monitoraggio piani di produzione;
♦ Supporto nella preparazione delle ispezioni GMP e HSE.

Requisiti:
♦ laurea in CTF, Farmacia o Ingegneria Chimica;
♦ ottima conoscenza dei principali tool informatici con focus particolare su Excel/Access;
♦ buona conoscenza della lingua inglese.

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Validation Engineers
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Are you looking for new and exciting challenges within validation?
Fujifilm Diosynth Biotechnologies (FDB) in Hillerød is expanding, and to ensure support to the growing number of equipment and systems, we are looking for Validation Engineers, who are sharing our passion, drive, and energy – to join our team.

We are looking for Validation Engineers who will complement the team’s current skills with experience in one or more of the below listed areas:
- Qualification / Validation of process equipment (upstream)
- Cleaning validation
- Tech transfer of new products
- The role and responsibilities

You will be part of the validation team and participate in tech transfers of new products in the running production, you will perform qualifications and cleaning validations of new equipment/modifications and write the associated protocols/reports.

Other tasks (not limited to)
- Preparing, planning, performing, and documenting VPP, IQ, OQ and PQ activities
- Participating and assessing change controls, executing the different actions
- Planning and participation in key projects with validation impact
- Planning, preparing, executing, and documenting all phases of cleaning validation
- Writing and updating validation procedures and technical documents
- Participation in audits and inspections, answering regulatory requests

Qualifications
You hold a Bachelor or higher degree in Engineering or other relevant discipline and have at least 3 years of relevant industry experience. You have demonstrated knowledge of industry practices, practical experience, and interest in hands-on validation execution. You are conscious of lean ways of working and you are able to apply a risk-based approach to deliver efficient qualification. For this role you need to have strong technical writing and excellent communication skills, as you will have to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, etc.

You are a team player who enjoys working with colleagues and in cross-functional teams. As a person you bring a friendly, can-do behavior, professionalism, and a good sense of humor. You are independent and have a flexible, dynamic approach to work.

About the department and the team
The Validation team has the responsibility of ensuring the validated state of the running production systems within the large-scale manufacturing drug substance facility. The team is divided in upstream and downstream and they participate in tech transfer of products, qualification of new equipment and modifications as well as in larger projects.

The team consists of 8 FTE and 2 student helpers. We have good sense of humor in the team, and we are good at helping each other. We are good at integrating new hires into the team and give a thorough introduction to our systems. There are also a lot of social events within the department.

Location: Hillerød. Denmark

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Clinical Trial Assistant - Multisponsor
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Job Overview:
Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

Essential Functions:
• Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
• Assist with periodic review of study files for completeness.
• Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

Qualifications:
• Life Science Degree (Bachelor's + Master's).
• Previous administrative support experience in life sciences preferred.
• Equivalent combination of education, training and experience.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Written and verbal communication skills including good command of English language.
• Effective time management and organizational skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
• Knowledge of applicable protocol requirements as provided in company training.

Modalità (in presenza, smartworking, ibrida...): ibrida
Sede: Milano
Tipologia di contratto: indeterminato

Per candidarti a questa job vai sul sito di IQVIA carriere: https://jobs.iqvia.com/location/italy-jobs/24443/3175395/2

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Specialist - Single Use Systems and Primary Pack for Drug Product
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Are you a proactive Specialist thriving with being the go-to person? Do you bring curiosity and a mindset for developing within and mastering complex processes and technologies?

Then we hope you will be our new colleague in our Manufacturing Sciences and Technology for Drug Product (MSAT DP) department.

Your New Role
The area of Single Use systems (SU) and Primary Pack (PP) for DP is very dynamic and developing fast.

This means we do not necessarily require many years of experience with the area. Rather we expect you to have a few or more years of experience with SU and PP and a strong ability to get up to date and stay forward looking on top of trends, developments, and best practices in the area.

You will be the specialist and go-to person. You will provide process, technology, and design support for drug products to be manufactured at FDB – including during engineering runs, qualification, tech transfers and GMP mfg.

Main tasks
- Specialist on Single Use systems for transfer of bulk Drug Substance to formulation room, to filling room to point-of fill.
This includes single use bags for mixing / pooling and formulation of BDS, - Single use bags for liquid excipients and readymade buffers etc. - Single use transfer bags of weighed powders for closed system addition in formulation room, - Bioburden and Sterile filters incl setups for automated pupsit- bulk DP bags, - filling assemblies incl. surge bag and filling tubes and RTP port bags.
- Specialist in Primary containers (syringes, vials, cartridges, and closures including pressfits / snapfits and COP containers.
- Assessments of Primary packaging materials suppliers and SU suppliers processes In cooperation with TT leads and other scientists design proper SU systems for the Drug Products to be manufactured, ensuring best control of CQAs and adherence to Product Control and Contamination control strategies.
- Lead and ensure global aligned strategic approach to SU systems and primary pack in the large-scale organsation for Drug Product currently covering FDBD (Denmark) and FDBN (North Carolina).
- In cooperation with customers and other relevant MSAT resources ensure compatibility and E/L is properly assessed and acceptable for the solutions designed and developed for the specific Drug Product programs
- Supporting sourcing organization and others with inputs to material specification, incoming release criteria and ensuring proper Risk Profile around handling and assembly of SU systems, including Aseptic connections between SU elements.
- Keeping up to date with trends and regulations in the SU and primary pack space representing FDB with presentations on conferences, papers, articles, support to commercial presentations
Driving solution task forces in case of problems with SU systems and primary pack during manufacturing in case mfg. needs further help, and liaise with suppliers if necessary.

Skills & Talents
- Experience from the pharmaceutical industry working in a GMP environment. previous experience with SU and PP.
- Experience from working with process designs and Quality Risk Management strong interest and bandwidth for continually learning about new technologies, processes, and products.
- Strong communication skills in English.

We hope you are self-driven, proactively and excel in managing complex assignments.

Location: Hillerød, Denmark

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Farmacista - Nord e Centro Italia
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Sedi: Punti vendita distribuiti nel Nord e Centro-Italia* 
Modalità: 
in Sede – farmacia e/o parafarmacia
Tipologia di contratto: Tempo determinato o indeterminato in base all’esperienze e della sede

Descrizione delle mansioni:

  • consiglio e vendita alla clientela;
  • vendita di farmaci, parafarmaci e prodotti dermocosmetici;
  • erogazione di servizi quali: misurazione pressione, glicemia, colesterolo, peso, vitamina D;
  • analisi capello, pelle, cellulite;
  • analisi intolleranze alimentari;
  • test disbiosi;
  • sistemazione merce e attività di back office.

Lauree:  Farmacia e/o Chimica e tecnologie farmaceutiche

*Città punti vendita
Importante: specificare nella cover letter per quale/i città ci si candida!!!

  • Milano,
  • Monza-Brianza,
  • Cremona,
  • Varese,
  • Bergamo,
  • Brescia,
  • Lecco,
  • Tortona-Serravalle,
  • Cornate d’Adda,
  • Verona,
  • Vicenza,
  • Padova,
  • Parma,
  • Bologna,
  • Modena,
  • Sassuolo,
  • Ferrara,
  • Forlì-Cesena,
  • Prato,
  • Firenze,
  • San Giovanni Valdarno,
  • Roma
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Addetto QA
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La risorsa si occuperà di:
• Redazione e implementazione di policies e procedure per il rispetto delle normative italiane ed estere
• Gestione delle deviazioni, OOS e relativi CAPA
• Gestione dei changes
• Revisione della documentazione di produzione
• Gestione degli audit interni ed ai fornitori
• Gestione degli audit ricevuti dai clienti
• Training al personale
• Ogni attività volta al mantenimento di un adeguato livello di qualità nel rispetto delle correnti GMP.

Requisiti:
• Laurea in Chimica, CTF o Farmacia
• Ottima conoscenza della lingua Inglese
• Conoscenza del pacchetto Office
• Ottima capacità organizzativa e predisposizione al lavoro in team
• Rilevante capacità di root cause analysis e problem solving
• Eventuale breve esperienza già maturata in ambito QA, regolatorio o presso un laboratorio Controllo Qualità, sarà considerata un plus.

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Associate, Accounts Payable
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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.

This role is located in Copenhagen, Denmark, and is hybrid.

The Role & Department
The Associate Accounts Payable will be part of our global Finance and Accounting Team which collaborates as a strategic partner to clients, vendors and all internal departments. It's a hands-on role where the successful candidate will be responsible for running and continuously improving our local accounts payable processes to support our rapid growth and operations.

Key responsibilities include

  • Processing daily accounts payable and ensuring the follow-up of all outstanding items
  • Daily review of invoices on-hold and keeping pressure on purchasers for quick resolution
  • Reviewing invoices for appropriate documentation & approvals prior to payment
  • Preparing and processing payment batches
  • Review daily T&E employee expense reports via Concur
  • Timely and adequately responding to all internal and external queries
  • Work closely with other teams to ensure prompt resolution of PO related issues
  • Review and action promptly on all A/P balances, mismatching, refunds & adjustments
  • Month end closing activities & reconciliations
  • Contributing to the working environment by displaying a positive attitude and a high work ethic

Requirements
Moreover, you meet the following professional requirements:

  • Minimum of 1-2 years' experience in Accounts Payable/Finance; good understanding of the purchase-to-pay process
  • Knowledge and understanding of ERP systems (SAP is a plus)
  • Extensive knowledge and understanding of Microsoft Office suite
  • Excellent in English (written and spoken)
  • Danish reading level (ability to read Danish invoices)
  • Proven experience working in teams
  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines
  • Ability to be proactive, enthusiastic and goal oriented
  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Data Managers, Clinicians, vendors labs) to support product development strategy
  • Strong communication skills - both oral and written

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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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BRR & Investigation Specialist
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La risorsa si occuperà di:
- Gestire le Deviazioni e le Investigazioni relative alle problematiche di qualità dei lotti fabbricati, garantendo il rispetto delle tempistiche previste.
- Coordinare e gestire il sistema CAPA derivante dalle investigazioni di qualità.
- Supportare la preparazione di report periodici di qualità destinati alla direzione e alla corporate.
- Gestire le non conformità in ricezione di materie prime, principi attivi e materiali GMP. Partecipare attivamente a iniziative e progetti nell'ambito dell'Operational Excellence.
- Collaborare con le diverse funzioni aziendali per definire le cause delle deviazioni e delle investigazioni e attuare il piano di azioni correttive.
- Verificare l'efficacia delle azioni correttive nel tempo.
- Partecipare alle visite dei clienti e alle ispezioni di qualità (Audit).
- Fornire formazione al personale coinvolto nelle attività di quality compliance per DPS.
- Partecipare alla stesura di FMEAs.

Requisiti:
- Laurea in Biologia, Farmacia, CTF o Biotecnologie.
- Almeno 1 anno di esperienza in Quality Assurance/Quality Compliance, preferibilmente in aziende che producono farmaci sterili.
- Buona conoscenza dell'inglese, sia scritto che parlato.
- Doti di problem solving.
- Proattività e capacità di lavorare in team.
- Ottime capacità di comunicazione e negoziazione.
- Eccellenti doti organizzative.

Si offre contratto in somministrazione di 6 mesi con possibilità successiva di inserimento in azienda, con livello di inquadramento commisurato all’esperienza maturata.

Sede: provincia di Frosinone

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Young Professionals Pipeline for Automation Engineers | Hillerød, Denmark
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1,2 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 young 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.

We’ll match your profile proactively with relevant positions. Once a Hiring Manager shows interest in your profile, the Hiring Manager Team will reach out to you and tell you more about the current position and invite you for the 1st Interview.

We look forward to receiving your application and to having the opportunity to provide a solid match for open positions.

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

About the positions
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: Automation engineers and process digitalization (www.novonordisk.com)

Qualifications
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

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.

Check list when applying
- When choosing your privacy settings, please select: “Profile Visibility: Novo Nordisk Recruiter Worldwide”
- You do not need to attach a cover letter to your application, and please make sure to delete previous cover letters from your profile
- We encourage you to include a few sentences about why you are interested in the position in your CV
- To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV
- Make sure to apply to each location that you are interested in separately. For example, if you want to work in Kalundborg or Hillerød, you need to apply to both the Kalundborg and Hillerød pipeline job post
- We kindly ask you to withdraw your application if you are no longer interested

Location: Hillerød, Denmark

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Process Supporter Pipeline
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1,2 Calling all scientists and engineers! Are you ready to take the first (or next) step in your career within Pharmaceutical Manufacturing, where you can develop and enhance your professional- and personal skills to the next level? Are you interested in working in one of the fastest growing pharmaceutical companies, that aims to improve the lives of millions of patients worldwide? And have you either recently graduated your studies, or perhaps you already have experience working with data analysis, process systems and descriptive and prescriptive analytics?

Then you might be the next Process Supporter to join one of our many production sites in Greater Copenhagen, Denmark.

The position
We are looking for Process Supporters who have an interest in understanding pharmaceutical processes, developing monitoring tools and analyzing data for recommendations and improvements. Furthermore, you have an interest in business impact and understanding how interconnected decisions play a crucial role when manufacturing pharmaceuticals.

Specifically, you will
- Analyze large amounts of data for extracting correlation and causation for process understanding
- Analyze and understand data from quality control (QC) analyses
- Develop, maintain, and recommend statistical process control charts for process monitoring - Use a science, data-based approach for quantifying process deviations
- Use a team-based approach for recommending process improvements-optimizations.

This job gives you a great opportunity to play a part in shaping the future of manufacturing across the organization, in close collaboration with teach-transfer in Novo Nordisk.

Qualifications
Process Scientist candidates should have the following qualifications:
- An academic degree (MSc for graduates and at least a BSc if you have work experience) within chemistry, natural science, engineering or in a related field
- Ability to independently understand scientific principles required for manufacturing pharmaceutical substances related to the interaction of chemistry and equipment
- Ability to monitor data and extract information
- A curiosity for connecting the understanding of process science to product quality
- An appetite for solving complex problems applying a systems approach to manage complexity and reach feasible applicable solutions.

For all our Process Support positions, it is key that you understand how to convey complex information to varying audiences and thereby, explain the purpose to get everyone onboard. In addition, you should have proficient oral and written communications skills in English.

Location: Copenhagen Area, Denmark

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Stage Medical Affairs – Milano ( area Oncoematologia/Ematologia)
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Sede: Milano
Modalità: ibrida
Tipologia di contratto: STAGE curriculare o extracurriculare di 6 mesi, con possibilità di proroga. È previsto un rimborso spese e buoni pasto.

Sanofi, azienda multinazionale farmaceutica, sta ricercando per la propria sede di Milano una risorsa da inserire in stage all'interno del dipartimento Medical Affairs della Unit Specialty Care, in area Oncoematologia/Ematologia. La risorsa supporterà il Tutor di riferimento in tutte le attività legate al dipartimento, partecipando attivamente e ricevendo formazione on the job.

Le attività di cui si occuperà saranno principalmente:
♦ Supporto nella preparazione di materiali per i medical meetings (es slides/elaborazione presentazioni power point), advisory board, SRC, riunioni di ciclo e riunioni interne;
♦ Supporto attivazione consulenze;
♦ Supporto gestione amministrativa degli studi ISS/ESC e studi sponsored, NPP;
♦ Supporto gestione PSP (tracking/status/reports);
♦ Supporto nelle preparazione/gestione degli slide kit, in caso di richiesta, negli eventi esterni;
♦ Supporto nella preparazione/gestione operativa di agenzie esterne coinvolte in “ADB – Medical writing – partnership";
♦ Tracking delle attività legate ai congressi Onco-Ema e Tracking attività esterne condivise con gli MSL;
♦ Supporto negli eventi Stand alone, Webinars etc;
♦ Supporto per stesura minute delle riunioni;
♦ Supporto amministrativo al processo di approvazione dei materiali medical (inserimento materiali e rinnovo materiali);
♦ Supporto per ricerche bibliografiche in collaborazione con Medical Information.

Requisiti:
♦ Laureascientifica;
♦ Costituisce un plus avere un PHD in Biologia molecolare/oncologia;
♦ Buona conoscenza del pacchetto office;
♦ Ottima conoscenza della lingua inglese.

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Regulatory Affairs Officer
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Siamo alla ricerca di un/a Regulatory Affairs Officer con specializzazione in ambito cosmetico e/o nutraceutico da inserire nel team Affari Regolatori.
La risorsa, rispondendo al Regulatory Affairs Manager e collaborando con il team regolatorio dell’HQ di Gruppo, dovrà occuparsi delle attività regolatorie e di sicurezza legate ai diversi ambiti della nostra produzione, specializzata nello sviluppo e nella produzione di dermocosmetici e integratori alimentari.

Tipologia di contratto: Stage semestrale full time con rimborso spese e concrete prospettive di continuità, in base all’esperienza del candidato.

Modalità: in presenza

Sede: HQ – Mereto di Tomba (UD) / Gallarate (VA) / Monselice (PD)

 

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Controller finanziario
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Requisiti:
- Laurea in Scienze, Tecnologia, Ingegneria, Matematica, o Finanza.
- Esperienza di 2/3 anni nel controllo di gestione preferibilmente in aziende del settore produttivo.
- Esperienza precedente in FP&A o Controllo.
- Forti abilità analitiche e di raccolta dati. Attenzione ai dettagli e consegna costante di lavori di alta qualità.
- Capacità di gestire molteplici priorità e stringenti richieste di tempo.
- Eccellenti competenze con MS Excel; preferibile conoscenza di Oracle, HFM/CMR, SAP Analytics Cloud (SAC).
- Ottime conoscenze dell'inglese.
- Abilità efficaci di comunicazione verbale e scritta.
- Solide capacità di costruzione di team e dimostrata capacità di lavorare con un gruppo diversificato di persone, anche se geograficamente disperse.
- Auto-motivato, elevato livello di flessibilità e forte etica lavorativa con l'obiettivo di portare a termine il lavoro.
- Approccio al Miglioramento Continuo: Identificare lacune nei processi e nei controlli e promuovere iniziative di miglioramento attraverso il Practical Process Improvement (PPI).

Responsabilità:
- Coordinare le attività di chiusura contabile e garantire una reportistica accurata nel processo di chiusura mensile.
- Condurre analisi delle visioni finanziarie consolidate, creare report chiave per il team di senior management.
- Potenziare la conoscenza della reportistica finanziaria nel sito.
- Revisionare mensilmente i dettagli dei ricavi, delle spese e dei dipendenti, identificando i fattori chiave che guidano le variazioni rispetto al Piano Operativo Annuale e alla previsione. Supportare la preparazione del piano operativo annuale e delle revisioni aziendali mensili e trimestrali.
- Svolgere progetti speciali e analisi finanziarie ad hoc.
- Promuovere il miglioramento continuo e la standardizzazione dei processi di reportistica e analisi per aumentare la produttività ed efficienza.
- Fornire supporto al processo di CAPEX (ritorno sugli investimenti).
- Condurre audit SOX/Statutari.

Contratto:
Il contratto offerto è in somministrazione in base al CCNL Chimico Farmaceutico livello C1/B2 e avrà una durata fino alla fine del 2024, con possibilità di rinnovo in base alle esigenze aziendali.

Sede: provincia di Frosinone

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Young Professionals Pipeline for Automation Engineers | Kalundborg, Denmark
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1,2 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 young 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.

We’ll match your profile proactively with relevant positions. Once a Hiring Manager shows interest in your profile, the Hiring Manager Team will reach out to you and tell you more about the current position and invite you for the 1st Interview.

We look forward to receiving your application and to having the opportunity to provide a solid match for open positions.

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

About the positions
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: Automation engineers and process digitalization (novonordisk.com)

Qualifications
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

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.

Check list when applying
- When choosing your privacy settings, please select: “Profile Visibility: Novo Nordisk Recruiter Worldwide”.
- You do not need to attach a cover letter to your application, and please make sure to delete previous cover letters from your profile.
- We encourage you to include a few sentences about why you are interested in the position in your CV.
- To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.
- Make sure to apply to each location that you are interested in separately. For example, if you want to work in Kalundborg or Hillerød, you need to apply to both the Kalundborg and Hillerød pipeline job post.
- We kindly ask you to withdraw your application if you are no longer interested.

Location: Kalundborg, Denmark

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Percorsi di formazione per CRA e professionisti della Ricerca Clinica
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Metti a fuoco il tuo obiettivo

11 marzo 2024 | 28 marzo 2024
dal lunedì al giovedì dalle 9:30 alle 13:30
modalità: online\streaming

IL CORSO
Il corso ha una durata di 3 settimane e prevede una suddivisione di attività in 12 mezze giornate, fruibili da remoto in modalità streaming, con possibilità di interazione diretta con i docenti. Le lezioni sono erogate in lingua italiana e il materiale didattico fornito in lingua inglese.
Si propone di formare personale da inserire nel mondo del lavoro attraverso una rassegna dei cardini della ricerca, utili ai futuri operatori del settore.
Le macro aree affrontate sono impostate per coprire le attività indispensabili per GCP nella conduzione degli studi clinici.

Alla fine del corso i partecipanti otterranno un attestato di partecipazione (è necessario partecipare ad almeno il 90% delle ore previste) che costituirà elemento preferenziale per avere la possibilità di candidarsi a programmi di inserimento aziendale (stage) presso le associate che si renderanno disponibili, a seguito di un colloquio conoscitivo.

A chi ci rivolgiamo
Ci rivolgiamo a chi abbia conseguito il diploma di laurea magistrale per il ciclo di studi di Scienze della Vita o che sia iscritto all’ultimo anno di frequenza.
Inoltre il corso è aperto a giovani professionisti già inseriti nel mondo del lavoro che abbiano necessità di approfondire gli elementi chiave della ricerca clinica.
Le iscrizioni verranno accolte con un criterio temporale per ordine di arrivo, fino a un massimo di 25 partecipanti.

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Junior R&D studi di stabilità
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Siamo alla ricerca di un/una brillante neolaureato/a da inserire nel laboratorio R&D per supportare il team nella gestione dei piani analitici e degli studi di stabilità. La risorsa darà supporto e acquisirà crescente autonomia nella gestione delle attività di creazione.

Tipologia di contratto: Stage semestrale full time con rimborso spese e concrete prospettive di continuità, in base all’esperienza del candidato.

Modalità: in presenza

Sede: HQ – Mereto di Tomba (UD)

 

 

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QA Floor Support Specialist
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Per il nostro stabilimento di Sesto Fiorentino siamo alla ricerca di risorse da inserire nei reparti di produzione parenterale e di packaging con il ruolo di QA Floor Support Specialist. Le risorse riporteranno direttamente al QA Manager dell’area di riferimento e dovranno garantire il supporto tecnico/scientifico e di compliance di primo livello durante le attività di produzione e che la documentazione dei Batch record sia conforme agli standard di qualità.

Principali responsabilità del ruolo:

  • Garantire che le pratiche operative dei reparti di produzione assegnati siano in compliance con standard qualitativi aziendali ed in conformità alle GMP;

  • Eseguire troubleshooting su problematiche di processo, intervenire in seguito ad anomalie ed essere il primo riferimento in campo per la gestione difetti

  • Eseguire la valutazione dei cicli macchina, degli allarmi di processo e di quelli relativi al reparto di produzione

  • Collaborare con i team di processo per l’investigazione di deviazioni e l’implementazione di change

  • Collaborare alla prepazione delle ispezioni

  • Autorizzare la ripartenza della produzione dopo interventi di manutenzione straordinaria

  • Supportare la scrittura delle procedure ed eseguire attività di Batch review

  • Svolgere il ruolo di osservatore durante l’esecuzione del Media Fill

  • Può erogare training per SOP, corsi e QP/LV agli operatori di produzione

Requisiti minimi richiesti:

  • Laurea Magistrale in discipline scientifiche (Chimica, CTF, Biologia, Biotecnologie, etc)

  • Buona conoscenza della lingua inglese (livello minimo richiesto B2)

  • Buona conoscenza del Pacchetto Office

  • Conoscenza delle GMP e della produzione farmaceutica

Requisiti aggiuntivi/preferenziali:

  • Capacità di team-working e di decision making

  • Esperienza pregressa nel ruolo, maturata preferibilmente in contesti farmaceutici produttivi/ambito parenterale

Si richiede la disponibilità a lavorare su turni, anche notturni.

 

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QC Technician
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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.

Experienced Lab Technicians for a new QC laboratory

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.  Are you skilled in performing analytical testing in a GMP laboratory (such as (U)HPLC, icIEF, CE-SDS, ELISA etc)  and do you want to impact the establishment of a brand-new GMP QC Laboratory for Genmab?

The role

  • The laboratory, based in Ballerup is responsible for supporting Genmab’s innovative products by performing release and stability testing according to ICH guidelines.
  • You will have great impact on shaping working culture and capabilities meanwhile taking responsibility on your daily tasks. Daily tasks include performing release and stability testing, establish and validate methods, support daily laboratory task and support and train fellow lab technicians.
  • We use an integrated LIMS system, and it will be great if you have experience with this.

Responsibilities

  • You will play a key role in the laboratory which includes authoring and reviewing initial laboratory procedures, implement, qualify and maintain equipment and validate analytical methods.  
  • Additionally, collaboration and cross-site training with our analytical development group in Utrecht, NL, and our analytical SME´s in Copenhagen is expected.
  • Continuous improvement of laboratory capabilities will be a natural part of daily tasks which includes optimization of workflows and build on IT systems.
  • Prior experience with LIMS is highly appreciated.

Requirements

  • You are a trained Lab Technician
  • You have at least 5 years of documented professional experience with analytical methods in a QC setting
  • You have practical experience in conducting biochemical and physico-chemical analyses (i.e HPLC, CE-SDS, icIEF or ELISA)
  • Experience with qualification of analytical instruments is desirable.
  • You are comfortable with IT systems controlling analytical instruments in particular LIMS

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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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Manufacturing Associates
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For the Drug Substance Manufacturing Unit in Hillerød, Fujifilm Diosynth Biotechnologies is looking for Manufacturing Associates (Process Operators) to support the expansion project.

FUJIFILM Diosynth Biotechnologies is currently expanding its capacity to support the large-scale production by adding 14 x 20,000L bioreactors and three downstream processing lines in Hillerød. The additional production capacity will make the facility the largest end-to-end Contract Development and Manufacturing Organization (CDMO) in Europe, offering a total of 20 x 20,000L bioreactors for drug substance production complemented by comprehensive drug product and finished goods services.
This is an excellent opportunity to join our company at a pivotal time of growth and be part of an exciting journey.

We are currently looking for candidates to support the expansion with the Commissioning Readiness of all Systems, to support Equipment Start-up and IOQ Testing. As well as performing the PQ in close collaboration with validation, executing water batches and technical batches with engineering. This is an excellent opportunity to get extensive knowledge on the manufacturing equipment before we go into production in 2024.

When the project is finished you will automatically be offered a job opportunity in two places. To continue with the next expansion project on site and carry along your learnings or our new Drug Substance Manufacturing department covering - respectively – Upstream & Downstream. The two departments cover different steps in the biopharmaceutical production such as Media Preparation, CIP & SIP of equipment, growth of cell cultures, and purification via multiple column steps.

During the time in the project,you will work either fixed day or fixed evening, 7 days during a 14-day period, including every other weekend.Please add in your application which shift or shifts you prefer.

The work schedule is as follows:
Week 1: Monday, Tuesday, Friday, Saturday, and Sunday
Week 2: Wednesday and Thursday

The shifts are as follows:
Day: 06:00 – 17:04
Evening: 13:00 – 23:13

Tasks
- Support and review design deliverables incl. drawings, data sheets, specifications and engineering lists.
- Perform field walk-downs and participate actively in daily/weekly/monthly meetings and ensure timely updates.
- Equipment preparation and testing.
- Reviewing Protocols and Work instructions.
- Executing PQ Protocols guided by work instructions.
- Trouble shooting.

Qualifications
We are looking for process operators, preferable with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate who have recently finalized their bachelor’s or master’s degree relevant for Biologics Manufacturing and are keen on starting their career in a manufacturing and international environment where things move fast. It is a plus if you have experience with cGMP and/or SOPs or knowledge of chromatography and filtration processes.

You will get the opportunity to customize your development plan in agreement with your manager based on your wishes and qualifications.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools. You are very quality-oriented and thorough. You are proactive, responsible, organized and able to take ownership of tasks. Furthermore, you are a good team player who thrives on setting a good example. You must be keen on learning new things, and the first period will of course include thorough training.

Location: Hillerød, Denmark

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Master farmaceutico e biomedicale Scienziati in Azienda
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Master farmaceutico e biomedicale
Master Scienziati in Azienda
XXV Edizione | 11 settembre 2024 | Campus Baveno o Live Streaming

Master Full time con stage retribuito per giovani laureati e laureandi in discipline scientifiche, interessati a perfezionare la propria formazione con l’obiettivo di inserirsi in imprese del settore BioPharma.
94% Placement delle precedenti edizioni.

Quali opportunità in azienda dopo la laurea scientifica?
Dopo la tua laurea in discipline scientifiche, partecipa a un percorso formativo di alta specializzazione. Completa la tua formazione universitaria con le competenze di management e una conoscenza approfondita delle professioni del settore farmaceutico e biomedicale. Alla fine del Master avrai acquisito un nuovo mindset, unito a strumenti di intervento che ti permetteranno di avere conoscenza ampia del settore per iniziare una strada di successo in campo professionale.

Iscriviti a Scienziati in Azienda: il Master che forma le figure più ricercate dalle aziende farmaceutiche e biomedicali oggi.

Il Master Scienziati in Azienda ti darà accesso a competenze di alto profilo con le quali costruire la tua carriera nel settore dell’Healthcare e Life Science.

Nella prima parte del Master imparerai come funziona un’azienda farmaceutica, scoprirai i meccanismi interni al sistema sanitario, e svilupperai le soft skills indispensabili per intraprendere una carriera in azienda.
Nella seconda parte, affronterai i moduli specialistici che ti guideranno passo per passo attraverso il percorso che un farmaco o un medical device deve attraversare dallo sviluppo, al trial fino al suo ingresso nel mercato attraverso strategie di market access, marketing, vendita e comunicazione.

Scopri i vantaggi del Master presso il nostro campus di Baveno o in Live Streaming. Potrai partecipare al Master in forma flessibile – dual mode, scegliendo la formula più adatta alle tue esigenze: in aula, presso il Campus di Baveno, o in live streaming da remoto, interagendo sempre con Faculty e compagni.

Sarai tu a scegliere la modalità di partecipazione, avendo garantiti – sia in presenza che in digital learning – tutti i servizi e plus del Master: contenuti e risorse, placement, career coaching, progetti collaborativi, stage retribuito, contatti con le imprese.

Le lezioni in aula o in live streaming sono pianificate dal lunedì al venerdì dalle ore 9:00 alle 18:00.

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Junior QC analyst
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Siamo alla ricerca di una figura junior da inserire nel team QC (chimico-fisico e microbiologico).

La risorsa affiancherà i colleghi nello svolgimento delle analisi chimico fisiche avvalendosi dell'uso di apposita strumentazione, e sarà coinvolta nelle attività di controllo e gestione dei bollettini di analisi e delle specifiche tecniche delle materie prime e dei semilavorati, dei referti delle analisi eseguite da laboratori esterni.


Tipologia di contratto: Stage semestrale full time con rimborso spese e concrete prospettive di continuità, in base all’esperienza del candidato.

Modalità: in presenza

Sede: HQ – Mereto di Tomba (UD) / Gallarate (VA)

 

 

 

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Senior Associate, HRS Business Analyst
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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

As a Senior Associate in HR Systems at Genmab, you will play a key role in the maintenance, support, and enhancement of our HR technology platforms. Your expertise will ensure our HR systems operate smoothly, support our global workforce efficiently, and align with our HR strategies and business goals. You will be at the forefront of optimizing our solutions to enhance user experience, improve system functionality, and support our growing organization.

Focused on our specialized platform support outside of our HCM, including Phenom, ServiceNow and many more which compliment our core system [Workday]. Offering opportunities to learn HR System Landscaping and wider functionalities while working with partners across the HR function to support and resolve sophisticated problems faced by the business.

This role will include being included in strategic projects and improvements, co-ordinating multiple requirements and platform updates, needing to work strategically with collaborators in and outside HR.

Key Responsibilities:

  • Provide end-to-end support for multiple HR systems, including system enhancements and maintenance to ensure optimal performance.
  • Collaborate with teams to implement system improvements and integrations that align with organizational needs and strategies.
  • Assist in the management of HR system projects, from planning and design to execution and evaluation, ensuring they are delivered on time and within scope.
  • Develop and maintain detailed documentation for HR systems processes, workflows, and guidelines to support user training and standard processes.
  • Analyze system processes to generate insights and recommendations for enhancing system functionality.
  • Serve as a key liaison between HR and HR departments, facilitating effective communication and collaboration on HR system-related matters.
  • Ensure compliance with data protection laws and regulations across all HR systems

Requirements

  • Bachelor's degree, equivalent experience or demonstrated ability in Human Resources, Information Technology, Business Administration, or related field.
  • Experience 3-5 years in HR, System maintenance or other related field
  • Solid understanding of HR processes and how they are supported by technology.
  • Proficient understanding of HRS platforms (e.g., Workday, SuccessFactors, Oracle HCM) and MS Office Suite.
  • Excellent analytical, problem-solving, and project management skills.
  • Good communication and interpersonal skills, with the ability to engage effectively with both technical and non-technical partners.
  • Ability to work independently and as part of a team in a fast-paced, global environment.

For US based candidates, the proposed salary band for this position is as follows: $71,250.00---$118,750.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

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

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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Quality Assurance Associate
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Eli Lilly Italia is looking for a Quality Assurance Associate to join the Manufacturing Team in Sesto Fiorentino. He/She will report to the Sr Manager of the production department (sterile or packaging & device lines) and will be responsible for ensuring the application of cGMP and Lilly standards. Moreover, he/she will be part of the cross-functional team of the area and will be responsible for managing Quality issues as the Quality contact within the team. Responsibilities of the role may vary depending on seniority and increasing complexity of the process.

Main Responsibilities of the role:

  • Being accountable for the escalation process in case of issues in the production area

  • Supporting the preparation and ensuring readiness to any Regulatory inspection; supporting site self-inspection program

  • Participation to investigations related to the area, in cooperation with other functions and the cross-functional team

  • Performing Quality Assessment of observations and deviations in Trackwise

  • Having the role of CSQA of the team and approving CHG

  • Performing Batch Review and Batch Disposition of semi-finished products

  • Reviewing procedures, QP/LV and acting as instructor of some courses and procedures

  • Executing the process monitoring for Quality and providing information for writing documents such as APR, AQMS

  • Being the Media Fill observer

  • Approving work orders, if applicable

  • Cooperating in site Quality Systems and Quality Culture initiatives

Minimum Requirements:

  • Scientific Master’s Degree

  • Good knowledge of English (at least B2 CEFR)

  • Understanding of Quality principles and their applications in pharmaceutical manufacturing

  • Knowledge of current GMP's, pharmaceutical legislation and regulatory requirements

  • Prioritization skills and ability to determine the criticality of Quality issues

  • Problem solving skills and decision-making attitude

Additional Skills/Preferences:

  • Experience in pharmaceutical industry operations is preferred

  • Knowledge of sterile and packaging manufacturing processes

  • Communication and influencing skills

  • Good team working/partnership skills to working within a cross-functional organization

  • Pragmatic approach and compliance mindset

 

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Manager, eTMF Oversight
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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.

Overview
The role will be responsible for the clinical oversight of the eTMF as established within Genmab’s procedural documents, GCP-ICH guidelines, and regulatory health expectations. This role is not study specific but is rather overarching to support all Genmab studies. A core part of this role is to support eTMF inspection readiness activities and support the Director, eTMF Management Team Lead with tactical implementation strategies related to eTMF. In this position, the employee will be responsible for supporting critical eTMF initiatives, acting as an eTMF Subject Matter Expert (SME), and driving continuous improvement with internal and external stakeholders.

Responsibilities

  • The key accountability of this role is to oversees eTMF inspection readiness by driving internal and external stakeholders to be eTMF compliant., by:
  • Remaining up to date with GCP-ICH guidelines, regulatory standards and TMF industry updates.
  • Performing eTMF oversight activities across all Genmab trials to ensure inspection readiness (quality, completeness, and timeliness filing of records).
  • Conducting internal and external TMF SME training as needed.
  • Attending or hosting internal and external meetings as needed.
  • Overseeing CRO partners to ensure eTMF tasks are performed per our Work Orders (WOs)/Change Orders (Cos), Standard Operating Procedures (SOPs) and Work Instructions (Wis).
  • Mentoring new eTMF Oversight team members.
  • Supporting as the SME for any eTMF process related questions via the eTMF Management Mailbox, email, and training.
  • Supporting TMF Plans e.g., assist in the creation, document approver, answer questions, etc.
  • Monitoring KQI/KPI and eTMF dashboards/reports for trends and outstanding eTMF tasks regarding quality, completeness, and timeliness.
  • Supporting stakeholders with their spot checks e.g., training and answering questions of the process.
  • Maintaining the eTMF Indexing Key based on user and process owner input to ensure ongoing compliance, enhancements and escalate, as needed.
  • Informing contributors of important eTMF updates e.g., Indexing Key updates, major changes in GenDocs eTMF, CRO agreements related to filing in eTMF.
  • Performing eTMF audit trail reviews.
  • Performing GenDocs eTMF User Access reviews per SOP.
  • Supporting in the development of eTMF processes and training.
  • Uploading (and reviewing) controlled templates in eTMF.
  • Supporting activities related to trial master file data visualization dashboards and applications to support clinical trial oversight and inspection/audit activities, in collaboration with the Clinical Trial Oversight group, 
  • Supporting with relevant departmental activities e.g., due diligence activities, forums/workshops, contribute to knowledge sharing sessions, participate in the development and implementation of new methodologies and procedures related to the eTMF to ensure Development Operations’ work is compliant and of high quality.
  • Coordinating eTMF oversight activities with internal and external stakeholders.
  • Supporting Senior Associate, eTMF Oversight with portfolio level inspection readiness activities.
  • Supporting inspection readiness activities related to eTMF oversight e.g., Inspection Readiness Handbook.
  • Developing inspection/audit material (slides, storyboards, etc.), participating and presenting on eTMF processes during inspection/audits.
  • Supporting with document collection during inspections, in addition to the Function Area (FA) SME/representatives.
  • Supporting eTMF post inspection/audit action items/activities.
  • Providing archival support as the appointed eTMF Archivist.
  • Supporting the development, testing and training of eTMF AI initiatives.

Qualifications

  • Fluent English (oral and written).
  • Bachelor's Degree is required.
  • 5 years of experience working in clinical research required, eTMF preferred. 
  • Proficiency in the use and understanding of an eTMF system, Veeva Vault preferred.
  • Thorough understanding of the eTMF index structure (CDISC TMF Reference Model).
  • Familiarity with all phases of the drug development processes (discovery to market), including key clinical trial documentation, Oncology area experience preferred.
  • Previous experience with WO, TMF plans, TMF reviews and KQI/KPI assessments.
  • Operational knowledge to be able to perform their role in accordance with ICH-GCP, internal SOPs and guidelines.
  • Understanding/knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with clinical trial and regulatory documents (e.g., protocols, investigator brochures, and clinical study reports).
  • Experience in driving process improvement through insights, previous experience etc.
  • Capable of using creative yet pragmatic problem-solving approaches to cut through ambiguity, complexity, and deliver tangible results.
  • Ability to build strong internal and external stakeholder relationships. 
  • Powerful communicator with the ability to consolidate and convey complex information with a clear voice.
  • Ability to create and deliver effective oral presentations and educate stakeholders.
  • Strong interpersonal and communication skills in English.
  • Active listener with excellent analytical and documentation skills ensuring attention to detail and the highest level of accuracy.
  • A team player but also able to work independently.
  • Solution-driven and a dedicated colleague with a pragmatic business approach and thrive with managing a wide range of stakeholders and tasks and the ability to work both collaboratively and autonomously.

The Employee shall also render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.

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

Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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Quality System
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Teva, leader mondiale con oltre 40.000 dipendenti nel settore dei farmaci equivalenti, con un business differenziato che comprende anche farmaci specialistici, da banco e la produzione e commercializzazione di principi attivi farmaceutici, è presente in Italia da oltre 25 anni con una filiale commerciale e stabilimenti produttivi. La nostra missione è semplice: migliorare la vita dei nostri pazienti. Ci prendiamo cura del loro benessere così come dei nostri collaboratori, creando un ambiente basato sul rispetto, sulla diversità e sull’inclusione, impegnandoci a mantenere alti standard di qualità, compliance e sicurezza, rispettando sempre i nostri valori. Noi tutti ci sentiamo parte di una sola realtà e collaboriamo per raggiungere un obiettivo comune.

Tra le attività di supporto che il tirocinante svolgerà a contatto con il tutor vi saranno:
- Inserire a sistema i dati relativi ai training effettuati
- Supporto nella gestione dell’attività di training dello stabilimento
- Supporto nel processo di revisione delle procedure del Sistema Qualità dello stabilimento
- Supporto nell’inserimento delle SOP a sistema
- Supporto nell’esecuzione della revisione periodica dei risultati di controlli analitici di acqua, controlli ambientali e varie utilities

Requisiti:
- Laurea in CTF, Farmacia, Chimica o affini
- Buone capacità relazionali e organizzative
- Autonomia e flessibilità
- Conoscenza della lingua inglese, livello B2
- Ottimo utilizzo del pacchetto Office
- Si offre iniziale stage di 6 mesi.

Sede: Rho, Milano
Rimborso spese mensile di €800,00 e accesso gratuito alla mensa aziendale.
Contratto di lavoro: Tempo pieno, Tirocinio formativo/stage.

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QC AD & GMP Scientist
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Sei uno scienziato appassionato nel campo dello Sviluppo Analitico e delle GMP?
Se hai una laurea in CTF, Chimica, Biologia o campi correlati, e hai esperienza nell'industria farmaceutica con un focus sul Controllo Qualità, questa è un'opportunità straordinaria per te! Collaboriamo con una rinomata azienda che opera nel settore della ricerca e sviluppo di nuovi farmaci per cercare uno Scienziato esperto nel Settore Sviluppo Analitico e delle GMP.

Requisiti:
- Laurea specialistica in CTF, Chimica, Biologia o campi affini.
- Esperienza nell'industria farmaceutica, con particolare focus sul Controllo Qualità.
- Conoscenza delle principali tecniche di analisi chimico-fisica e biochimica, nonché della validazione di metodi analitici.
- Familiarità con le normative GMP e regolamenti nazionali/internazionali. Ottime capacità di risoluzione dei problemi.
- Conoscenza approfondita dei software Microsoft Office e strumenti analitici/statistici (Empower, MiniTab, Sample Manager).
- Capacità di gestire priorità contrastanti, rispettando scadenze, in un ambiente dinamico. Ottima conoscenza della lingua inglese.

Responsabilità:
- Supervisione delle attività analitiche di laboratorio in conformità con i requisiti GMP, fornendo supporto per attività analitiche legate a API/DS e prodotti finiti (rilascio e stabilità).
- Redazione di specifiche analitiche, protocolli e relazioni di studio, metodi analitici e SOP in conformità con le normative vigenti (EU GMP, US GMP) e gli standard di qualità aziendali.
- Coordinamento con il Team Leader/Supervisore per la gestione del cliente, mantenendo un elevato livello di soddisfazione e completando le attività richieste nei tempi previsti.
- Partecipazione a chiamate/riunioni con i clienti per supportare la discussione su temi tecnici della propria area di competenza.
- Collaborazione con il Team Leader/Supervisore nell'identificare i requisiti per il trasferimento tecnologico analitico dai clienti, garantendo un trasferimento corretto ed efficace nei laboratori.
- Collaborazione con il Team Leader/Supervisore nella gestione delle indagini di laboratorio (Out of Specification e Deviation Reports).

Contratto:
Il contratto offerto è in somministrazione in base al CCNL Chimico Farmaceutico e avrà una durata fino alla fine del 2024, con possibilità di rinnovo in base alle esigenze aziendali. Il livello di inquadramento varia in base all'esperieza maturata dal candidato.

Sede: Provincia di Frosinone

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Young Professionals Pipeline for Automation Engineers | Copenhagen, Denmark
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1,2 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 young 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.

We’ll match your profile proactively with relevant positions. Once a Hiring Manager shows interest in your profile, the Hiring Manager Team will reach out to you and tell you more about the current position and invite you for the 1st Interview.

We look forward to receiving your application and to having the opportunity to provide a solid match for open positions.

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

About the positions
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: Automation engineers and process digitalization (novonordisk.com).

Qualifications
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

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.

Check list when applying
- When choosing your privacy settings, please select: “Profile Visibility: Novo Nordisk Recruiter Worldwide”
- You do not need to attach a cover letter to your application, and please make sure to delete previous cover letters from your profile
- We encourage you to include a few sentences about why you are interested in the position in your CV
- To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV
- Make sure to apply to each location that you are interested in separately. For example, if you want to work in Kalundborg or Hillerød, you need to apply to both the Kalundborg and Hillerød pipeline job post
- We kindly ask you to withdraw your application if you are no longer interested

Location: Greater Copenhagen Area, Denmark

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QC Chemical Laboratory Technician
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Eli Lilly Italia, per lo stabilimento di Sesto Fiorentino, è alla ricerca di risorse da inserire in qualità di QC Chemical Laboratory Technician.

Le principali responsabilità del ruolo saranno legate a:

  • Esecuzione test analitici in conformità alle metodiche e normative previste
  • Test quantitativi e qualitativi su materie prime
  • Test strumentali e test di controllo caratteristiche chimico-fisiche su prodotto finito e su prodotti in stabilità
  • Analisi chimiche su API ed eccipienti
  • Campionamento e analisi fluidi di stabilimento
  • Preparazione di reagenti e soluzioni per test analitici in accordo con GMP e SOP aziendali
  • Manutenzione generale e calibrazione della strumentazione di laboratorio
  • Gestione ed interpretazione di dati e risultati analitici con utilizzo di software per strumentazione di laboratorio (Empower, SmartLab)
  • Presa in carico dei campioni e immissione dei relativi a sistema tramite software Darwin LIMS

Le risorse dovranno inoltre occuparsi di:

  • Assicurare il rispetto e applicazione delle GMP e corporate standards nell’area di competenza assegnata
  • Collaborare quotidianamente con il reparto HSE per garantire la messa in sicurezza di infrastrutture e personale aziendale di laboratorio
  • Gestire il flusso dei reagenti chimici (presa in carico, stoccaggio, smaltimento) e gestire la strumentazione del laboratorioù
  • Partecipare alla pulizia e al buon mantenimento del laboratorio

Requisiti minimi richiesti:

  • Laurea Magistrale in Chimica o CTF
  • Conoscenza strumentazione laboratorio chimico (i.e. HPLC, spettrofotometro IR e FTIR, pHmetro, conducimetro, centrifuga, Elettroforesi)
  • Conoscenza della lingua inglese (livello B2)
  • Attitudine al team working
  • Attenzione al dettaglio


Si richiede la disponibilità a lavorare su turni mattina/pomeriggio.

 

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Process Scientist and Process Engineer Pipeline
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1,2 Are you looking for a life-changing career within Pharmaceutical Manufacturing? Novo Nordisk is a global healthcare company employing 47,000 employees worldwide. At our Manufacturing Hub in Kalundborg, Denmark, we are hiring Process Scientist and Process Engineer graduates.

Are you recently graduated or someone working in the industry with focus on or interest in data analysis, process systems and, descriptive and prescriptive analytics? Are you interested in understanding pharmaceutical processes, developing monitoring tools and analyzing data for recommendation for improvements? Are you interested in business impact and understanding how interconnected decisions play a crucial role when manufacturing pharmaceuticals? Then you can be one of our Process Scientists or Process Engineers at our Manufacturing Hub in Kalundborg, Denmark.

The position
We are looking for someone who is motivated by and enjoys analyzing data, making sense of that data using descriptive and prescriptive analytics and, developing and maintaining process monitoring systems.

Specifically, you will
- Analyze large amounts of data for extracting correlation and causation for process understanding
- Analyze and understand data from quality control (QC) analyses
- Develop, maintain, and recommend statistical process control charts for process monitoring
- Use a science, data-based approach for quantifying process deviations
- Use a team-based approach for recommending process improvements-optimizations

This job gives you a great opportunity to play a part in shaping the future of manufacturing across the organization, in close collaboration with teach-transfer in Novo Nordisk.

Qualifications for Process Scientists
Process Scientist candidates should have the following or developing qualifications:
- An MSc in Chemistry, Biochemistry, Protein Chemistry, Biophysical Chemistry or (Bio-) Analytical chemistry
- Ability to independently understand scientific principles required for manufacturing pharmaceutical substances related to the interaction of chemistry and equipment
- Ability to monitor data and extract information
- An appetite for connecting the understanding of process science to product quality

Qualifications for Process Engineers
Process Engineer candidates should have the following or developing qualifications:
- An MSc in chemical, industrial or mechanical engineering (or a BSc with some professional experience)
- Ability to analyze data and independently extract information
- An appetite for solving complex problems applying a systems approach to manage complexity and reach feasible applicable solution

For both Process Engineers and Process Scientists it is key that you understand how to convey complex information to varying audiences and thereby, explain the purpose to get everyone onboard. In addition, you should have proficient oral and written communications skills in English.

Location: Kalundborg, Denmark

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