Otsuka Pharmaceutical Companies (U.S.)
Denver, CO, USA
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...
