Associate Director, Formulation and Drug Product Development
Core
Lead formulation development and drug product development for bioconjugate therapeutics targeting neuromuscular diseases, ensuring manufacturability, quality, and stability for clinical trials.
Role type
Associate Director, Formulation and Drug Product Development
Builds
Bioconjugate drug products (high-concentration subcutaneous formulations, lyophilized products) for clinical trials
Domain
Biotechnology / Neuromuscular diseases / Drug Product Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP manufacturing, sterile fill-finish, lyophilization, subcutaneous formulation development, tech transfer, scale-up, IND/IMPD filing support, CDMO management, container closure selection
Preferred skills
None stated
Technologies
None stated
Responsibilities
Act as subject matter expert for drug product development including formulation and sterile fill finish; Serve as main point of contact for CDMOs for external formulation development; Build internal laboratory capabilities for formulation development; Drive development, tech transfer, and scale-up of drug product processes; Contribute to early-stage clinical filings (INDs/IMPDs); Collaborate cross-functionally to ensure drug supply continuity; Execute formulation development plans at CDMOs
Seniority
Senior, hands-on IC
