Director, Formulation Development

Role: Lead formulation development for oral drug products, overseeing strategy and execution from preclinical to Phase 3, registration, and technology transfer. Responsibilities: manage internal teams and external CROs/CMOs, establish phase-appropriate formulation and manufacturing plans, oversee vendor selection and governance, and ensure regulatory compliance and documentation for INDs, NDAs, and other filings. Collaborate with cross-functional teams including Analytical Development, Regulatory CMC, Quality, and Clinical Supply to meet program milestones. Requirements: PhD/MSc in pharmaceutical sciences, chemical engineering, or related field; at least 15 years of pharma development experience with a focus on oral dosage forms; 5+ years of leadership in virtual or outsourced environments. High-Value: expertise in tablet/capsule formulation, process scale-up, process validation, GMP manufacturing, and global regulatory submissions; experience managing external partners and cross-functional teams; up-to-date knowledge of cGMP, FDA, EMA, ICH guidelines. WorkSetup: hybrid Irvine-based role with remote options; travel up to 30%.