Maurice A. Marsini

WORK HISTORY

EDUCATION

SKILLS

ABOUT MAURICE A. MARSINI

Strategic Leadership- Head of CMC Process Chemistry - highly experienced representative of drug substance organization in senior leadership meetings, providing integrated strategic input across portfolio while driving internal PR & D innovation- CMC Program Lead - effectively devised and executed implementation of Drug Substance, Drug Product, Analytical, Clinical Supply Chain, Shipping/Logistics, and CMC Regulatory strategy for preclinical and clinical assets. Major emphasis on preformulation/API integration with substantial oversight/support of DP strategy across multiple assets and formulation concepts for phases Experienced builder and leader of high-performing teams conducting internal lab PR & D and managing external manufacturing to deliver non-GMP & GMP material on multi-kilogram scale across a preclinical/clinical portfolio- Highly effective relationship cultivator, synergistically advancing multiple programs by relying on CDMO partners- Key value-oriented, technical business partner supporting CMC due diligence activities for multiple assets- Seasoned teacher/mentor at the undergraduate, graduate, and industrial levels; as a team leader, I am passionately committed to professional and personal development emphasizing core values, transparency, and trust- Intuitive, organizationally aware people manager - I effectively manage people towards success beyond project goals.Technical Expertise- Manager, developer, and lead of phase-appropriate, multi-kilogram-scale manufacturing campaigns supporting critical CMC drug development, Phase clinical trial supplies, and regulatory/commercial readiness- Highly capable in strategic route scouting, process optimization, impurity control, fate/purge, crystallization, and cGMP synthesis of Active Pharmaceutical Ingredients (APIs) in a safe, compliant, and quality-conscious environment- Strong collaborator with technical understanding of non-DS CMC workflow and integration with API delivery- Outstanding communicator; regularly achieves optimal collaboration with departmental counterparts and effective matrix-management of internal/external resources to ensure development timelines are met- Routine manager of multiple vendors/programs in parallel while maintaining on-time deliveries- Subject matter expert (SME) for several CPI projects, familiar with lean methodology- Presenter of original research in peer reviewed journals, national conferences, and internal project review meetings.