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Analytical CMC Specialist

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

The CMC area of Genmab is growing and looking for an Analytical CMC Subject Matter Expert (SME) to join the CMC Late Stage Manufacturing Development (LSMD) Team.

As the Analytical Subject Matter Expert (SME), you will be part of a highly dedicated and specialized CMC team leading the late stage development activities of Genmab’s proprietary antibody pipeline programs towards marketing approval (BLA/MAA).

The Analytical SME will work across project teams to support the CMC Project Managers and work closely with other SMEs for e.g. upstream processing, downstream processing, and characterization as well as with relevant SMEs within partner programs.

Responsibilities

The Analytical SME will be responsible for the following:

  • Responsible for the LSMD analytical strategy on ongoing projects

  • Responsible for the day to day oversight of analytical activities performed at partnered CMOs according to latest industry standards and regulatory guidance

  • Prepare/review technical documents including development/validation/transfer protocols and reports

  • Authoring and review of CMC regulatory analytical submissions documents

  • Work closely with characterization SME’s to develop late stage development analytical/characterization strategies

  • -Support defining/refining required processes for analytical/characterization activities

Requirements

  • It is expected that you have a master’s degree in natural science, pharmacy, or similar

  • You have at least 5 years of documented professional experience with analytical methods for GMP manufacturing preferable from late stage development

  • You have a thorough understanding of the detailed requirements for analytical validation and are up to date with current trends

  • You preferable have active and recent experience within analytical development and validation of methods for biologics/monoclonal antibodies from a phase II/III program

  • You preferably have experience with chromatographic and pharmacopeia methods for biologics. Experience with other analytical methods is also desirable

  • You preferably have experience in establishing commercial specifications

  • Expertise in applied statistics for (bio)pharmaceutical manufacturing is a plus

  • It is preferred that you have experience in preparing and reviewing relevant filing documentation for regulatory market authorizations (e.g. BLA, MAA, J-NDA)

  • Excellent communication skills in English written and oral

Moreover, you meet the following professional requirements:

  • You are focused on achieving goals that are important for the team and our organization

  • You have the ability to work successfully under pressure in a fast-paced environment and with tight timeline

  • You are pro-active, take initiative and responsibility

  • You are a team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders

  • With your positive attitude you enjoy working in multicultural teams inside and outside of Genmab

 

Degrees of interest: master’s degree in natural science, pharmacy, or similar

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