Process Development Senior Scientist
Core
Lead drug product development strategy and execution for early clinical synthetic molecule programs, focusing on oral solid dosage forms for complex molecules like PROTACs and molecular glues.
Role type
Senior IC process development scientist (oral solid dosage forms)
Builds
Robust, scalable, phase-appropriate formulations for IND-enabling studies and GMP clinical manufacturing
Domain
Biopharmaceuticals / Oncology / Synthetic molecules
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Formulation development for oral solid dosage forms, Process scale-up and technology transfer, GMP clinical manufacturing support, Regulatory documentation (INDs, CTAs), Cross-functional team leadership, Risk management for drug development, Biopharmaceutics and material properties understanding, Enabling solubility formulation technologies
Preferred skills
Experience with advanced synthetic modalities (degraders, PROTACs), Hands-on experience with hot melt extrusion (HME) and spray dried dispersions (SDD), Industry experience in early clinical drug product development, Experience authoring regulatory documentation for CMC submissions
Technologies
Hot melt extrusion (HME), Spray dried dispersions (SDD), GMP manufacturing systems
Responsibilities
Lead drug product development strategy and execution for early clinical synthetic molecule programs, Design and execute formulation and process development experiments for oral solid dosage forms, Partner with internal and external manufacturing partners to support scale-up and technology transfer, Author and review technical and regulatory documentation including INDs and CTAs, Present technical strategies and development plans to cross-functional teams, Contribute to continuous improvement of formulation and process development capabilities
Seniority
Senior, hands-on IC
