Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)
Core
Lead the Development and Commercialization Team (DCT) to deliver an integrated CMC development and commercialization strategy for biologics, ensuring robust processes, tech transfer, regulatory filing, and uninterrupted commercial supply.
Role type
Director, Biologics CMC and Commercialization
Builds
Commercial biologics products with robust CMC strategies and supply chains
Domain
Biopharmaceuticals / Biologics / CMC
Required skills
Biologics development, CMC strategy, Tech transfer, Regulatory filing (BLA), Commercial supply chain management, Cross-functional leadership, Risk mitigation, Process optimization, Strategic planning, Stakeholder influence
Preferred skills
Technical product stewardship, Large molecule commercialization, Global regulatory requirements, Business and financial acumen
Technologies
Product management systems, CMC tools
Responsibilities
Execute end-to-end DCT deliverables including control strategies and tech transfer packages; Lead the DCT to assess deliverables and mitigate risks; Ensure best science and robust processes in collaboration with DCRC; Represent CMC in governance bodies and drive decisions; Comply with cGMP and global regulatory requirements.
Seniority
Director, Strategic & Enterprise Leadership