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Specialist Stability Operations

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

The Role

Genmab is now searching for a Specialist Stability Operations to join the CMC Stability and Submission Support Team in Copenhagen.

The CMC Stability and Submission Support Team is part of CMC Operations in Copenhagen, which are now close to 60 employees. CMC Operations is responsible for development and manufacture of Genmab drugs used in preclinical, clinical, and commercial settings. The team handles the stability studies of Genmab drugs used in clinical trials, as well as support submission activities for both first-in-human studies (IND/CTA), amendments and BLA/MAA.

As a Specialist within Stability Operations you thrive with working as part of a team while you at the same time can work independently. For this specialist position you will; (1) be part of a dedicated CMC management team, where you will be responsible for the stability studies for a specific Genmab drug in clinical trials, and you (2) will work with optimizing the GxP processes and GxP system used to handle stability studies at Genmab. 

As a stability specialist being responsible for stability studies for a Genmab drug, you will be working as part of a dedicated project specific CMC management team. Here you will be handling the stability protocols, stability report, data, trending, ensuring timely reporting of stability data, and shelf-life setting. 

In regards of optimizing the GxP processes and GxP system employed for stability studies at Genmab, you will be part of a cross-functional team and will also be expected to work independently. You will also lead efforts to enable fully automatic data transfer of stability data from our manufacturing networks into Genmab’s own digital stability system. Additionally, your work could include maintenance of stability data in Genmab’s stability database and support Stability Subject Matter Experts.

You will be joining a newly established team which reports to Associate Director CMC, Stability and Submission Support team. The team works in collaboration within CMC Operations and other departments as e.g. QA and RA. For the right person, this is a unique opportunity to join a growing company and team. Your support to the team will aid to further build on the Genmab 2030 vision to fundamentally transforming the life of people with cancer and other serious diseases. 

Responsibilities


The responsibilities will include, but not be limited to: 

  • Incoming data control and verification of stability data received from Genmab’s contract manufacturing network
  • Support monitoring and trending of stability of Genmab drugs used in clinical trial and help with setting of Expiry date
  • Establish and maintain stability protocols and reports
  • Support Out of Specification, Out of Trend or Out of Expectation events in collaboration with the Stability SME, QA and RA.
  • Revise current manual data entry into Genmab’s stability data base and enable fully automatic and digital stability data transfer into Genmab’s stability data base
  • Ensure full data integrity of Incoming stability data received from Genmab’s contract manufacturing network via newly implemented digital services.
  • Responsible Specialist for transition of current stability data base to a LIMS system
  • Enable a system for automatic data transfer and verification of stability data into regulatory submissions in relation to Genmab drugs used in clinical trials and commercial.
  • Perform assigned stability tasks in accordance with Genmab’s GMP quality system and procedures
  • Support the maintenance of CMC Operations’ quality system

Requirements

  • You hold as a minimum a bachelor’s degree within natural science
  • You have a worked with digital systems used for oversight of stability data in the pharmaceutical/biopharmaceutical industry with at least 3-5 years’ industry experience preferable from a company with clinical or marketed products
  • Experience with stability of pharmaceuticals/biopharmaceuticals in clinical or commercial environment.
  • Experience with handling/developing/improving stability processes in a GMP environment, preferably also a systems perspective with the ability of SOP authoring.
  • Experience of LIMS systems used for handling and monitoring stability, preferably also experience with implementation of LIMS system. Knowledge of software tools as e.g. iStability® or LabVantage are meriting.
  • Good knowledge of GMP/ICH/regulatory requirements within the field of stability, data integrity and ALCOA principles.
  • Experience with computer systems validation/GAMP and implementation of digital systems/software in a GMP environment is meriting

Moreover, you meet the following personal requirements:

  • You have a quality mind set and are able to prioritize your work in a fast paced and changing environment
  • You have a structured and systematic approach, flair for IT and user software/LIMS systems
  • Team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programs
  • You are organized with a sense of details
  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab
Degrees of interest: Bachelor’s degree within natural science

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