Director, Oral Drug Product Development
Core
Lead scientific and strategic leadership for the development of small molecule oral drug products, focusing on formulation, process development, and clinical manufacturing readiness.
Role type
Senior IC drug product development director (oral small molecules)
Builds
Small molecule oral dosage forms (solid, liquid, peptide) for clinical and commercial use
Domain
Biopharmaceuticals / Oral Drug Product Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Formulation design, process development, scale-up, technology transfer, CMC development, regulatory submission documentation, cross-functional team leadership, mentoring scientists and engineers
Preferred skills
Enabling technologies (amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations), late-stage development, NDA/MAA support, oral solid dose manufacturing unit operations, external CDMO/CMO management
Technologies
Amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, particle engineering
Responsibilities
Lead formulation design, process development, manufacturability assessment, scale-up, and technology transfer; Develop enabling approaches for challenging compounds (poorly soluble/permeable, peptides); Serve as senior representative on cross-functional CMC teams; Influence portfolio decisions on developability and risk; Champion technology transfer and clinical manufacturing readiness; Mentor and develop scientists and engineers; Oversee regulatory submission documentation; Implement new formulation technologies and digital workflows
Seniority
Director, Management Level