Lead drug product development and clinical manufacturing activities across multiple programs, with a strong focus on early- to mid-stage small-molecule oral solid dose compounds
Job Summary
Lead drug product development and clinical manufacturing activities across multiple programs, with a strong focus on early- to mid-stage small-molecule oral solid dose compounds.
Serve as the primary drug product CMC lead, partnering closely with internal cross-functional teams and external CDMOs to advance the company’s pipeline.
Prepare and review CMC sections of regulatory submissions, including INDs, NDAs, CTDs, etc., and interact with regulatory agencies.
Matching Summary
Lead drug product development and clinical manufacturing activities across multiple programs, with a strong focus on early- to mid-stage small-molecule oral solid dose compounds.
Skills & Requirements
Must-have
Small-molecule oral solid dose development
Preclinical to clinical supply
Formulation and process development
Regulatory submissions (INDs, NDAs)
CDMO management
Nice-to-have
Real-time molecular-resolution measurements
Nobel Prize winning founders
Setting up in-house labs
Key Requirements
Master's degree with 8+ years experience or PhD with 6+ years experience
Experience with various dosage forms and manufacturing processes
Proven track record of successful FIH formulation development
Strong understanding of FDA and EMA regulatory requirements