Associate Director, CMC, Drug Product
Core
Lead non-clinical and early-phase clinical formulation and process development for small molecule drug products, managing CDMO selection and regulatory documentation for IND/NDA/MAA filings.
Role type
Associate Director, CMC, Drug Product (Early-stage formulation & process development)
Builds
Drug substance attribute profiles, developability assessments, first-in-human formulations, and clinical trial materials for small molecule assets.
Domain
Biopharmaceuticals / Neuroscience / Small molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Small molecule drug product development, CDMO management, cGMP regulations, regulatory filing authoring, cross-functional collaboration, leadership
Preferred skills
PK exposure modeling, enabled formulations (spray drying, HME, lipid softgels, nano-formulations), parenteral dosage forms, buccal/sublingual formulations
Technologies
Spray drying, granulation, blending, bottling, blistering, hot melt extrusion, SEDDS/SMEDDS
Responsibilities
Lead non-clinical and early-phase clinical formulation development; manage CDMO selection and contracting; author and review CMC documents for regulatory submissions; coordinate clinical trial material manufacturing; evaluate drug product stability and packaging; manage audits and inspections of CDMOs.
Seniority
Senior, hands-on IC with management responsibilities