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.