Director, CMC Quality
Core
Technical quality expert for antibody products during clinical development through post-commercialization, ensuring product quality, regulatory compliance, and lifecycle continuity.
Role type
Director, CMC Quality (senior IC with leadership)
Builds
Antibody-based medicines (pre-filled syringes, autoinjectors) for patients
Domain
Biopharmaceuticals / Antibody therapeutics
Required skills
CMC quality leadership, global cGMP regulations, product & process control strategies, comparability strategies, regulatory guidelines interpretation, risk management, cross-functional collaboration
Preferred skills
MS or PhD in Life Sciences or Engineering, prior CMC Quality leadership experience, experience with pre-filled syringes and autoinjectors
Technologies
21CFR, EU GMP, USP, Ph. Eur., ICH, Health Canada FDA, EMA
Responsibilities
Lead CMC product Quality sub-team to define strategy and priorities; execute product strategy aligned with CMC development and regulatory filings; implement phase-appropriate control strategies; maintain Product Quality Risk Register; assess changes and deviations for quality impact; provide expertise for regulatory submissions and health authority inspections
Seniority
Director, strategic leadership and cross-functional alignment