Genmab
Senior Project Manager, CMC Life Cycle Management
DanmarkPosted 10 days ago
Full TimeSeniorDK
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Job Description
We are extra[not]ordinary *(ex· tra· not· or· di· nary |\ ik-ˈstr-not-ȯr-də-ˌner-ē) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and aut
Key Highlights
- Provide day-to-day project management support for commercial manufacturing activities at Genmab’s partnered CMOs, incl. change controls, deviations and release
- Collaborating with Regulatory Affairs, Commercial QA, CMC Late-Stage Development, MSAT and Commercial Supply Chain to drive cross-functional planning and execution
- Manage CMC commitments and support Post-Approval Change Management, incl. regulatory submission in collaboration with MSAT, Commercial QA, Regulatory CMC, CMC writing, and PD Development
- Support technical and operational items for product-specific roadmaps, e.g. line extensions, SKU expansion, dosage form modifications, or new market introductions, etc.
- Support initiatives to optimize yield, reduce cost of goods, and enhance robustness of manufacturing and testing processes
Qualifications
Required Qualifications
- Advanced degree (MSc or PhD) in Pharmacy, Chemistry, Biotech, Engineering, or a related scientific discipline
- Minimum of 7 years of experience in biopharmaceutical industry, preferably with therapeutic monoclonal antibody and/or protein development
- Proven track record in CMC project management across development and commercialization activities
- Prior experience with commercial product lifecycle management and oversight of Contract Manufacturing Organizations (CMOs) is considered an advantage.
- Broad understanding of global cGMP requirements and regulatory expectations across major markets
- Experience supporting the CMC technical sections of regulatory submissions and interacting with global regulatory authorities
- Excellent communication and stakeholder management skills, with fluency in English
- Demonstrated ability to work effectively in cross-functional and multicultural environments
- Strong organizational skills with the ability to manage multiple priorities, balance competing demands, and deliver against project timelines
- Team player with the ability to collaborate with diverse stakeholders.
- Result- and goal-oriented, committed to contributing to Genmab’s success
Skills & Technologies
Go
About the Company
Genmab
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
Danmark
Posted
10 days ago
Country
DK