Associate Director, MSAT - Analytical Sciences (Biologics)

Position Summary The Associate Director of MSAT (Manufacturing Science & Technology) - Analytical Sciences will serve as a scientific and technical leader supporting tech transfer, and commercial manufacturing of biologic drug substances and drug products. This role oversees analytical lifecycle management, method qualification/validation, comparability, control strategy implementation, and investigations. The ideal candidate brings deep expertise in biologics analytics, strong cross-functional leadership, and experience working with external contract manufacturing companies. Key Responsibilities Lead the analytical sciences function within MSAT to ensure robust support for commercial manufacturing of biologics (e.g., mAbs, fusion proteins). Drive analytical control strategy, specification setting, and lifecycle management in alignment with QbD principles. Oversee method performance monitoring and trending, analytical capability assessments, and continuous improvement initiatives. Provide analytical subject matter expertise (SME) during technology transfers to external manufacturing sites. Support manufacturing investigations by leading root-cause analyses, interpreting analytical data, and defining corrective and preventive actions. Guide method troubleshooting, resolution of OOS/OOT trends, and process-product linkages (CQA-CPP relationships). Lead analytical method qualification/validation strategy to meet Phase-appropriate and commercial requirements. Author, review, and approve analytical sections of regulatory filings (BLA/MAA, responses to agency queries). Partner with QA, Regulatory, and MSAT to ensure compliance with global regulatory guidelines (ICH Q2, Q6B, Q14, etc.). Partner closely with Process Development, Quality Control, Qu