Process Development Principal Scientist
Core
Lead Drug Product Teams to develop functional area strategies and execute Design of Experiments (DOE) for late-stage and commercial drug programs, focusing on oral solid dosage forms.
Role type
Principal Scientist (Process Development)
Builds
Commercial formulations and manufacturing processes for small molecule drugs
Domain
Biopharmaceuticals / Organic Chemistry / Solid State Chemistry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Organic chemistry, physical chemistry, solid-state chemistry, formulation research, DOE design, technical writing, regulatory filing support, unit operations knowledge, mentoring
Preferred skills
Patent application knowledge, scientific publication record, cross-functional collaboration, XRPD/DSC/TGA/SEM proficiency
Technologies
XRPD, DSC, TGA, SEM
Responsibilities
Design and execute experiments to support drug product development objectives; summarize results in technical documents and regulatory filings; mentor and supervise scientists; collaborate with cross-functional teams including QA, Regulatory, and Supply Chain; provide technical expertise on material properties and reactivity.
Seniority
Principal, hands-on IC with mentorship