Seeking an accomplished scientific leader to direct the strategy and execution of biologics drug substance programs, combining cross-functional CMC program leadership with deep expertise in cell line, upstream, and downstream process development to advance biologics through First-in-Human (FIH) milestones.
- Lead assigned early-stage Development and Commercialization Teams (DCTs), with accountability for integrated CMC strategy, milestone readiness, and advancement through governance decisions.
- Establish and lead matrixed CMC teams with clear structures, working groups, decision rights, timelines, escalation paths, and functional accountability.
- Coordinate strategy and execution across Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, pilot and commercial manufacturing, and external partners.
- Identify program risks, evaluate cross-functional trade-offs, develop data-driven contingencies, and provide clear recommendations to senior leaders and governance bodies.
- Define phase-appropriate drug substance strategies covering cell line development, upstream and downstream process development, scale-up, technology transfer, and clinical supply.
- Ph.D. in Chemical Engineering
- Biomedical Engineering
- Pharmaceutics
- Pharmaceutical Chemistry
- Pharmaceutical Sciences
Director of Preconstruction - CommercialNewReeves Young LLC · Nashville, US
Principal Scientist, Early DCT LeadMerck · Rahway, US