Associate Director, CMC, Drug Product
Core
Lead early-stage assessment and formulation development for small molecule drug products in pre-clinical and early Phase 1/2 clinical programs.
Role type
Associate Director, CMC, Drug Product (hands-on IC)
Builds
Drug substance attribute profiling, developability evaluations, and manufacturing process development for small molecule assets.
Domain
Biopharmaceuticals / Neuroscience / Small molecule drug product development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Small molecule drug product development, CDMO selection and management, cGMP regulations, regulatory filing documentation, cross-functional team leadership
Preferred skills
PK exposure modeling, enabled formulations (spray drying, HME, lipid softgels, nano-formulations), parenteral dosage forms, buccal/sublingual tablets
Technologies
Spray drying, granulation, blending, bottling, blistering, hot melt extrusion, SEDDS/SMEDDS
Responsibilities
Lead non-clinical and early phase clinical formulation and process development; Manage early-stage formulation development including drug substance attribute profiling; Coordinate clinical trial material manufacturing and packaging; Evaluate and manage qualified CDMOs and CROs; Author and review core CMC documents for regulatory submissions; Collaborate on global alignment of formulation strategies
Seniority
Senior, hands-on IC