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CMC Project Manager

The Role

Genmab is now searching for a Project Manager to join the Late Stage Manufacturing Development (LSMD) Team of CMC Operations in Copenhagen. The LSMD team is responsible for the late stage development activities of Genmab’s portfolio projects and preparation of the CMC package for regulatory filings.

As CMC Project Manager, you will support the CMC Lead of one of Genmab’s late stage development programs, and you will be responsible for the coordination and planning of activities performed at our partnered CMO’s. In doing so, you will work closely with SMEs for e.g. upstream/downstream processing, analytical validation and characterization. Furthermore, you will ensure that Genmab’s products going through the late stage development activities will be performed according to latest industry standards and regulatory guidance.

The LSMD team at Genmab is currently employing 19 people, and you will report to the Senior Director, Head of Late Stage Manufacturing Development, CMC Operations.

Responsibilities

The responsibilities of the CMC Project Manager will include, but not be limited to:

  • Responsible for the day-to-day CMC activities at our partnered CMO’s

  • Support the CMC Lead for strategy and execution of CMC development towards BLA/MAA

  • Support authoring and reviewing of regulatory CMC submissions (BLA, MAA, JNDA)

  • Support and follow up on CMO and internal quality events as e.g. changes or deviations

  • Support the maintenance of CMC Operations’ quality system

Requirements

  • You hold as a minimum a Master´s degree in relevant natural sciences

  • At least 4-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development

  • You have a proven track record and the technical skills of biological process development/biopharmaceutical manufacturing

  • Experience within CMC project management is required

  • As Genmab primarily uses Contract Manufacturing Organizations (CMOs) for development and GMP manufacture, experience in running projects with external partners is preferred

  • You have experience with the CMC technical sections of regulatory submissions, and interacting with global regulatory authorities

  • Excellent communication skills in English, written and oral

 

Moreover, you should be able to meet the following personal requirements:

  • Ability to work successfully under pressure in a fast-paced environment and with tight timelines

  • You possess the ability to manage multiple tasks, prioritize work and define steps needed to achieve project goals and team goals

  • Be a team player with the ability to collaborate with a diverse group of internal and external stakeholders

  • You are result- and goal-oriented and committed to contributing to the overall success of Genmab

Degrees of interest: MasterĀ“s degree in relevant natural sciences

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