Associate Director of CMC - Quality Assurance
Core
Develop and drive Quality (manufacturing and analytical) strategies for CMC activities (drug substance, API, drug product, and analytics) for radiopharmaceutical compounds in development.
Role type
Associate Director, CMC Quality Assurance
Builds
Radiopharmaceutical therapies for oncology patients
Domain
Biopharmaceuticals / Radiopharmaceuticals / Oncology
Required skills
cGMP knowledge, regulatory requirements (FDA/EU/ICH), change control management, risk assessment, analytical method lifecycle management, deviation/investigation/CAPA oversight, strategic planning, problem-solving, AI application
Preferred skills
biologics/sterile manufacturing experience, radiopharmaceuticals expertise, cleanroom environment experience, radioactive materials handling
Technologies
None stated
Responsibilities
Partner with technical SMEs to develop and approve CMC strategy for new drug candidates; manage change control for compound/product specific changes through the product lifecycle; review and approve analytical method life cycle documents; conduct risk assessments for drug development; collaborate with Regulatory on quality input for filings (IND/IMPD/BLA/NDA); act as final Quality reviewer/approver of Quality events and GMP documentation
Seniority
Senior, hands-on IC