Process Chemist Director
Core
Senior process chemistry leadership for development-stage small molecule programs, driving route scouting, optimization, scale-up, and technology transfer from early development through commercialization.
Role type
Director, Process Chemistry (Senior IC)
Builds
Robust, scalable drug substance manufacturing approaches for small molecule APIs
Domain
Pharmaceutical industry, small molecule drug development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> production drug substance manufacturing approaches
Required skills
synthetic route design, process optimization, scale-up, impurity control strategy, technology transfer, cGMP manufacturing knowledge, regulatory submission authoring/review, external CDMO oversight, cross-functional matrix leadership
Preferred skills
people management, Japanese language proficiency
Technologies
cGMP, CMC development tools, regulatory submission formats (IND, IMPD, CTD, NDA, MAA)
Responsibilities
Shape drug substance development strategies and process chemistry decisions; provide technical leadership on route selection and scale-up; oversee external process development and manufacturing at CDMOs; contribute to control strategies for APIs and impurities; support technology transfer and commercial readiness; provide technical input for regulatory submissions; partner with cross-functional teams for integrated CMC execution; facilitate scientific problem solving for process performance and robustness; mentor matrix team members; contribute to portfolio strategy and business development assessments.
Seniority
Director, strategic technical leadership
