Director, Drug Product

Role: Director of Drug Product overseeing formulation and process development from preclinical to commercialization stages, with a focus on Phase 1 and 2 clinical programs in oncology. Responsibilities: manage drug development activities, vendor relationships with CRMs, oversee GMP manufacturing, develop scalable formulations, and contribute to regulatory documentation, including INDs and filings. Serve as a bridge translating preclinical data into clinical dosage forms, ensuring regulatory compliance and process robustness. Requirements: MS/PhD in Pharmaceutical Sciences, Chemical Engineering, or related field; 8+ years in pharmaceutical/biotech industry with broad experience across preclinical to late-phase development; strong expertise in CMC, GMP, and dosage form development; proven leadership in external vendor management and cross-functional collaboration. HighValue: Oncology therapeutics, drug formulation, early to late-stage development, GMP compliance, regulatory submissions, vendor oversight, remote/hybrid work, domestic travel. Collaboration with internal teams (Pre-Clinical, Clinical, Analytical, Regulatory, Quality) and external CROs/CMOs.