Director, Biologics Development and Commercialization Team Lead (CMC Team Lead)
Core
Lead the Development and Commercialization Team (DCT) to deliver a fully integrated CMC development and commercialization strategy for biologics, ensuring robust processes, tech transfer, filing, and uninterrupted commercial supply.
Role type
Director, Biologics CMC Development and Commercialization
Builds
Commercial biologics products
Domain
Biopharmaceuticals / Large Molecule Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
CMC strategy, tech transfer, regulatory filing (BLA), commercial supply chain management, risk mitigation, cross-functional leadership, GMP compliance, capital management, manufacturing scale-up, sterile filling
Preferred skills
Technical product stewardship, commercialization of large molecule programs, global regulatory requirements for large molecules
Technologies
Product management systems, business and financial tools
Responsibilities
Execute end-to-end CMC deliverables including control strategies and tech transfer packages; lead the DCT to assess deliverables and mitigate risks; represent CMC in governance bodies to drive decisions; balance speed, cost, and robustness in product development; ensure compliance with cGMP and global regulatory requirements.
Seniority
Director, strategic leadership with hands-on technical oversight
