Remote Senior CMC Product Strategy Team Lead Director

Job Summary

A biotech research and development company needs applicants for an opening for a Remote Senior CMC Product Strategy Team Lead Director.

Individual must be able to fulfill the following responsibilities:

• Lead cross-functional Product Strategy teams in developing & implementing CMC strategies & activities for our multi-modality portfolio
• Ensure CMC teams deliver data and supply to enable FIH, Pivotal and Phase 4 Clinical studies
• Facilitate delivery of CMC sections of regulatory filings and ensure any RTQs are addressed in time to meet Program milestones

Qualifications Include:

• BS or MS in Biotechnology, Chemical Engineering, Biology, or Chemistry
• 20+ years of experience in the pharmaceutical industry with prior experience as a CMC team leader
• Knowledge of commercialization including Process & Product development, CMC Regulatory Affairs, Quality, Supply Chain, Biotech Ops
• Demonstrated competency and hands-on experience with typical CMC activities