Associate Director, Analytical Development and Quality Control (Small Molecules)

Role: Associate Director of Analytical Development and Quality Control, leading strategy and execution of analytical methods to support small molecule biopharmaceutical development from early research to commercialization. Responsibilities: develop and implement analytical strategies, oversee method development, validation, transfer, and compliance; support regulatory submissions (IND, IMPD, NDA, MAA); ensure methods meet ICH, FDA, EMA standards; guide comparability studies and support tech transfer; collaborate with cross-functional teams including Process Development, Quality, Regulatory, Manufacturing, and Discovery; evaluate new analytical technologies; serve on project teams and support inspections and audits. Requirements: Bachelor's in Chemistry, Biochemistry, or related; 8+ years in analytical development within biotech or pharma; strong expertise in solid oral dosage and biologics analytics preferred; experience with method validation, regulatory filings, and compliance; deep knowledge of ICH, FDA, EMA guidelines; excellent leadership and communication skills. HighValue: focus on small molecules, early to late-stage development, regulatory filings, GxP, cross-functional collaboration, analytical method validation, support for commercialization. WorkSetup: not specified; likely hybrid or on-site based on industry standards.