Sr. Principal Scientist, Tech Transfer
Core
Leads formulation and process development for solid dosage forms (tablets/capsules) from discovery through commercialization, ensuring regulatory readiness and technology transfer to CDMOs.
Role type
Senior Principal Scientist, Tech Transfer & CMC Strategy
Builds
Phase-appropriate drug products for neurological, psychiatric, endocrine, and immunological disorders
Domain
Biopharmaceuticals / Solid Dosage Formulation / CMC
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> product features (drug products)
Required skills
Solid dosage form formulation (tablets/capsules), cGMP compliance, process development (DoE, scale-up, validation), technology transfer to CDMOs, regulatory strategy (IND/NDA authorship), project management, team leadership
Preferred skills
Master's or PharmD degree, experience with analytical methods and stability programs, budget management
Technologies
Laboratory equipment for solid dosage manufacturing, regulatory submission tools
Responsibilities
Design and optimize robust drug product formulations, oversee global technology transfer and scale-up, manage external partnerships with CDMOs, lead CMC regulatory strategies, mentor team members, represent the company in manufacturing campaigns
Seniority
Senior, hands-on IC with strategic leadership