Upvote
Downvote
Head of Product Development And RegCMC, Biologics And Advanced Therapy Medicinal Products
Share Job
- Suggest Revision
Full-time
- The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets.
- The role has end-to-end CMC product responsibilities from pre-clinical to commercial life cycle process development activities, process platform strategies, and regulatory CMC management/filings across the biologics/ATMP modality portfolio.
- This role is ultimately accountable for delivering GMP-ready processes to manufacturing, phase-appropriate process optimization (i.e., COGS optimization), and regulatory CMC filing/approvability across all global healthcare regions.
- In addition to process and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO execution and strategy, regulatory filings, and manufacturing technology transfer.
- The leader guides, coaches, and develops team members to lead, collaborate, and engage in a matrix set of responsibilities with Biogen; this includes direct line reports as well as the facilitations of dotted line responsibilities of staff, and considerable partnership/alignment with Asset Development Program Management (ADPM) group.
Active Job
Updated 2 days agoSimilar Job
Relevance
Active