Director, Process Chemistry
Core
Lead process chemistry R&D for small molecule drug substances from early to late phase, designing processes for clinical and commercial supply.
Role type
Director, Process Chemistry
Builds
Clinical and commercial drug substance supply for small molecule programs
Domain
Biopharmaceuticals, Small molecule drug development (via careerplan.io/jobs/5140290008-director-process-chemistry-at-praxisprecisionmedicines)
Required skills
Process chemistry, CMC development, GMP compliance, CRO/CDMO management, Regulatory submissions, Manufacturing strategy, Budget management, Salt/crystalline form selection
Preferred skills
Continuous processing, Biocatalysis, Catalysis, High throughput experimentation, Oligonucleotide chemistry
Technologies
Lab equipment, Pilot plant systems, CRO/CDMO platforms
Responsibilities
Lead process chemistry R&D from early to late phase; Design early and late-phase/commercial drug substance processes; Lead demonstration from lab to pilot plant; Identify final API forms; Collaborate with CMC team on clinical and commercial delivery; Manage external CRO/CDMO partners; Author regulatory submissions; Define manufacturing strategy and GMP execution; Manage quarterly budgeting for drug substance activities.
Seniority
Director, strategic leadership with hands-on technical expertise