Director, Oral Drug Product Development
$188,000–$259,000 year
On-siteCambridge, Massachusetts, United States
Cambridge, Massachusetts, United StatesOn-siteFull Time$188,000–$259,000 yearSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Lead formulation design, process development, and scale-up for small molecule oral drug products across early- and late-stage programs. Develop enabling approaches for challenging compounds, including poorly soluble or unstable molecules, while championing technology transfer and clinical manufacturing readiness. Serve as the senior drug product representative on cross-functional CMC teams, driving alignment across regulatory, quality, manufacturing, and external partners. Influence portfolio decisions through assessmen
Required Qualifications
- PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry, or a related scientific discipline
- Minimum of 12 years' experience in oral drug product development
- Demonstrated track record leading formulation and process development for oral solid dosage forms from early development through clinical manufacturing and/or late-stage development
- Experience with scale-up, technology transfer, clinical manufacturing, and external manufacturing organizations
- Strong knowledge of CMC development, regulatory expectations, technical documentation, and phase-appropriate development strategies
- Proven ability to lead across functions, influence program strategy, manage technical risk, and communicate effectively with diverse stakeholders
- Experience mentoring, developing, or leading scientists and engineers
Desired Qualifications
- Deep expertise in enabling technologies such as amorphous solid dispersions, spray drying, hot-melt extrusion, lipid-based formulations, modified release, or particle engineering
- Experience with late-stage development, commercial readiness, process characterization, or process validation
- Experience supporting at least one NDA/MAA or commercial product and regulatory agency interaction
- Strong understanding and hands on experience with oral solid dose manufacturing unit operations and manufacturability considerations
- Experience implementing new technologies, digital tools, knowledge platforms, or best practices across multiple programs
- Demonstrated success managing external CDMO/CMO relationships and technology transfer activities
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