Director, Analytical Development and Quality Control (Biologics)

Role: Director of Analytical Development and Quality Control leading strategy and execution of analytical methods for biologics from early research to commercialization. Responsibilities: develop and validate cell-based assays, oversee analytical method transfer and qualification, support regulatory filings (IND, BLA, MAA), ensure compliance with ICH, FDA, EMA standards, and collaborate cross-functionally with Process Development, Quality, Regulatory, and Manufacturing teams. Requirements: Bachelor's in Chemistry, Biochemistry, or related; 10+ years in analytical development within biopharma; expertise in cell-based assay development; experience with regulatory submissions and validation; strong leadership and organizational skills. HighValue: biologics, cell-based assays, early to late-stage development, regulatory compliance, cross-functional collaboration, biotech environment. WorkSetup: competitive compensation with benefits, salary range $176,900–$221,219, flexible location considerations.