Senior Manager 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
Senior Manager of 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, biologics/sterile manufacturing experience, radiopharmaceuticals expertise, problem-solving, strategic thinking
Preferred skills
Prior Quality experience, AI application for team execution
Technologies
None stated
Responsibilities
Partner with technical SMEs to develop and approve CMC strategy; manage change control and oversee Quality System deliverables (Deviations, CAPAs); review and approve analytical method life cycle documents; conduct risk assessments; collaborate with Regulatory on filings; work in GMP cleanroom handling radioactive materials
Seniority
Senior Manager, hands-on IC with strategic oversight