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Upstream Processing 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 a Subject Matter Expert (SME) – Upstream processing (USP) to join the CMC, Late Stage Manufacturing Development (LSMD) Team.

As the USP 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 SME will work across project teams to support the CMC Project Managers and work closely with other SMEs for e.g. downstream processing, analytical validation, and characterization as well as with relevant SMEs within jointly developed partner programs.

Responsibilities

The USP SME will be responsible for the following:

  • Late stage development Upstream processing strategies on ongoing projects

  • Defining the scope for the late stage upstream development activities together with our CMO’s and partners according to latest industry standards and regulatory guidance

  • Oversight of the upstream activities preformed at partnered CMO’s e.g. trouble shooting, process characterization or process performance qualification

  • Prepare/review technical documents including development /tech transfer/process characterization reports, batch records, SOPs

  • Authoring and review of CMC regulatory submissions documents

  • Work closely with downstream processing SME’s to develop and align the late stage development characterization strategies

  • Support defining/refining required processes for USP activities

Requirements

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

  • You have at least 5-10 years of documented professional experience from the upstream CMC area, preferable from late stage development

  • You have a thorough understanding and overview of mammalian upstream processes together with an in-depth knowledge of upstream process characterization, risk assessment and late stage validation activities

  • It is preferred that you have experience in preparing and reviewing relevant filing documentation for regulatory market authorizations

  • It is preferred that you have statistical experience designing and evaluating DoE experiments

  • 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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