Formulation Project Leader (m/f/d)
Core
Lead formulation and manufacturing activities for late-phase oral drug product development, designing robust formulations and scalable processes.
Role type
Senior Formulation Project Leader
Builds
Oral solid dosage forms for clinical and commercial supply
Domain
Pharmaceutical development / Oral solid dosage forms
Required skills
Formulation design, Process development, Scale-up, Process transfer, Quality-by-design, DoE, CMC documentation, GxP compliance, Technical writing, Cross-functional collaboration
Preferred skills
PhD in Pharmaceutical Technology, Experience with PAT and modelling, Change management, Deviation handling
Technologies
SAP, PAT tools, Statistical analysis software
Responsibilities
Lead formulation development and manufacturing process activities for oral dosage forms, Develop and maintain project plans aligning formulation and manufacturing with program objectives, Generate and integrate scientific insight into drug substance and excipient properties, Apply structured experimental and data-driven approaches to support development, Act as key partner within cross-functional drug product sub-teams, Own and contribute to high-quality technical documentation including CMC reports
Seniority
Senior, hands-on IC with project leadership
