CMC Senior Project Manager
2 months ago
Genmab is seeking a highly skilled CMC Senior Project Manager to join the Late-Stage Manufacturing Development Team in Copenhagen.
This is a key position responsible for coordinating and planning CMC activities at Contract Manufacturing Organizations (CMOs) in support of Genmab's late-stage development programs.
Main Responsibilities
- CMC project management for late-stage development programs
- Internal alignment with the CMC Management Team
- Support for the CMC Lead in strategy and execution of late-stage development activities
- Regulatory CMC submissions (BLA, MAA, JNDA)
- Quality events and maintenance of the quality system
About You
- At least 3-5 years of experience in CMC project management
- Experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture
- Proven track record in biological process development and biopharmaceutical manufacturing
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