Hiring: Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC) Company: Genesis Molecular AI Location: San Diego, CA Job Posted Time: 2026-09-16 18:41:45 Employment Type: Contract Target Skills & Keywords : Agile, Diffusion Models, Risk Management About the job Experience: •12 years of industrial CMC experience OR MS in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific disciplines with at least 16 years of industrial CMC experience. •At least 12 years of industrial CMC experience OR MS in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific disciplines with at least 16 years of industrial CMC experience. Required Skills: •Strategic Portfolio Leadership: Establish and execute the global CMC strategy for the small molecule discovery and development pipeline, ensuring seamless transition from lead optimization to IND/CTA enablement. •Drug Substance (DS) Development & Scale-Up: Oversee phase-appropriate process chemistry, route scouting, crystalline form screening/polymorph evaluation, and scale-up strategies for critical active pharmaceutical ingredients (APIs). •Analytical and QC testing: Oversee DS and DP analytical strategy and scientific oversight across characterization, impurity and degradation-product control, reference standards, comparability, and stability. Oversee QC testing and data review for release and stability. •CDMO Management: Source, select, contract (MSA/SOW negotiation), and direct global Contract Development and Manufacturing Organizations (CDMOs). Monitor performance, tech transfers, and execution against milestones. •Regulatory Strategy & Compliance: Act as the primary technical authority for global health authority interactions (FDA, EMA). Author, review, and coordinate CMC modules of regulatory filings (INDs, IMPDs, CTAs, and future NDAs). Ensure adherence to phase-appropriate cGMP standards. •Cross-Functional Collaboration: Partner closely with Medicinal Chemistry, Discovery Biology, DMPK, and Clinical Operations to ensure molecule developability criteria are established early, and clinical trial material supply lines are secure. •Deep technical competence across API synthetic pathway optimization and modern drug product formulation methods for oral solid dosages. •Proven success leading Analytical Development and QC activities through external CDMOs, including technical oversight, issue resolution, and management of multiple programs and partners. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!