Late Stage Manufacturing Development Manager
2 days ago
The Senior CMC Project Manager will play a crucial role in supporting the CMC Lead and coordinating planning of activities performed at our partnered Contract Manufacturing Organizations (CMOs). As part of our Late-Stage Manufacturing Development (LSMD) Team in Copenhagen, you'll contribute to ensuring that Genmab's products meet the latest industry standards and regulatory guidance.
Key Responsibilities:
- Manage CMC activities at CMOs, focusing on Drug Product manufacturing.
- Internal alignment within the CMC Management Team governing a CMC program within Genmab.
- Support the CMC Lead for strategy and execution of CMC late-stage development activities towards BLA/MAA submissions.
- Support authoring and reviewing of regulatory CMC submissions.
- Support CMO and internal quality events.
- Maintain CMC Operations' quality system.
Requirements:
- At least 3-5 years of experience in CMC project management.
- 3-5 years of working experience with biopharmaceuticals, preferably with therapeutic monoclonal antibody or protein development and manufacture.
- Proven track record and technical skills in biological process development and biopharmaceutical manufacturing.
- Experience running projects with external partners preferred.
- GMP knowledge and insight into regulatory requirements.
- Excellent communication skills in English.
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Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create Alert Organic Chemist, Late-Stage Process Development Category: Research Location: Bagsværd, Capital Region of Denmark, DK Are you a science-driven person with a deeply rooted interest in organic chemistry and experience from drug substance process development or Active Pharmaceutical Ingredient (API)...
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Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full timeSelect how often (in days) to receive an alert: Create AlertOrganic Chemist, Late-Stage Process DevelopmentCategory: ResearchLocation: Bagsværd, Capital Region of Denmark, DKAre you a science-driven person with a deeply rooted interest in organic chemistry and experience from drug substance process development or Active Pharmaceutical Ingredient (API)...
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