• Own and lead the end-to-end drug product development strategy, including pre-formulation, formulation development, scale-up, and clinical manufacturing. • Serve as the technical lead for all drug product activities with CDMOs, including selection, oversight and troubleshooting • Provide strategic guidance on raw material sourcing, manufacturability, product quality risk assessments, and lifecycle management considerations. • Identify and proactively mitigate technical, regulatory, and supply risks; develop contingency strategies to ensure program continuity. • Author, review, and approve drug product CMC sections for regulatory submissions (IND/CTA and amendments), and represent Drug Product CMC in regulatory agency interactions. • Lead technical due diligence efforts, including CDMO evaluation, proposal review, data integrity assessments, and master batch record approval. • Establish and implement robust experimental strategies, including design of experiments (DoE), to optimize formulation and process development. • Mentor and provide scientific leadership to internal team members and consultants; elevate organizational capabilities in drug product development. • Lead process readiness activities for Pre-Approval Inspections (PAIs), ensuring manufacturing processes, documentation, validation packages, and technology transfer records are inspection-ready and aligned with regulatory expectations