Principal Scientist, Formulations

Role: Lead formulation development and manufacturing scale-up for small molecule oral drug candidates in early clinical stages. Responsibilities: design, optimize, and scale robust formulations aligned with target profiles; oversee process development, technology transfer, and GMP manufacturing; manage external CDMOs, review production records, and ensure quality compliance; support regulatory documentation including INDs and IMPDs; serve as a technical liaison across R&D, Supply Chain, QA, and external partners. Requirements: PhD in Pharmaceutical Chemistry, Formulation Sciences, or related field; 8+ years industry experience in formulation, process optimization, scale-up, and GMP manufacturing of small molecule oral/parenteral dosage forms; deep knowledge of QbD, cGMP, and regulatory standards; experience managing CDMOs and authoring regulatory documents. Preferred: strong cross-functional leadership, excellent communication, multitasking skills, and proven success in clinical-stage drug development. High-Value: small molecule drug products, oral solid dose, early-phase clinical development, GMP manufacturing, CDMO management, regulatory documentation (INDs/IMPDS), cross-disciplinary collaboration. WorkSetup: not specified.