Genesis Molecular AI
Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC)
San Diego, CA · On-site · Director · Full-time · Posted Sep 14, 2026
- Experience
- At least 12 years of industrial CMC experience with a PhD, or at least 16 years with an MS.
- Education
- PhD or MS in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals, or a closely related scientific discipline.
About the job
Leads small-molecule CMC strategy and development from candidate selection through clinical development, directing external partners, technical development, and regulatory submissions.
What you'll do
- Set global CMC strategy and oversee drug substance synthesis, process optimization, scale-up, and formulation development.
- Direct analytical and QC strategy, stability and release testing, and CDMO selection, contracts, transfers, and delivery.
- Lead CMC regulatory interactions and filing content, ensuring phase-appropriate cGMP compliance and clinical material supply.
What they ask for
- PhD in a relevant scientific discipline and at least 12 years of industrial CMC experience, or MS in a relevant discipline and at least 16 years.
- Technical competence in API pathway optimization and oral solid dosage formulation methods.
- Hands-on experience developing, transferring, troubleshooting, and validating small-molecule DS and DP analytical methods across early and late stages.
- Knowledge of cGMP laboratory operations, global regulatory expectations, and relevant ICH guidance; demonstrated success authoring and defending CMC filing sections.
Tools
CDMOs, FDA, EMA, cGMP, ICH, INDs, IMPDs, CTAs
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