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Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC)

Genesis Molecular AI· R&D
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San Diego, CAFull-timePosted 1mo ago

About the role

Strategic and technical leader for small molecule portfolio development from candidate selection through clinical development, managing external CDMOs to drive DS synthesis, process chemistry optimization, scale-up, and DP development; combines deep synthetic organic chemistry and preformulation with regulatory strategy and cross-functional leadership.

Responsibilities

  • 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).
  • Formulation & Drug Product (DP) Design: Lead preformulation characterization (solubility, stability, solid-state properties) and formulation development, focusing on maximizing bioavailability for challenging architectures via enabling technologies like amorphous solid dispersions, nanomilling, or lipid-based delivery.
  • 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 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 with Medicinal Chemistry, Discovery Biology, DMPK, and Clinical Operations to establish developability criteria early and secure clinical trial material supply lines.

Qualifications

  • PhD in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific discipline with 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.
  • 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.
  • Extensive hands-on experience in method development, transfer, troubleshooting, and validation for small molecule DS and DP across early and late-stage development.
  • In-depth knowledge of cGMP laboratory operations, global regulatory expectations and relevant ICH guidance.
  • Demonstrated history of authoring and defending high-quality CMC sections for regulatory filings.
  • Executive presence, negotiation capabilities, and strong communication skills to translate complex technical risk to executives and teams.
  • Motivated team player with strong critical thinking, independence, creative problem-solving, integrity, and adaptability to project changes.

Skills

Required:CMC strategy and leadershipAPI synthesis and process chemistryFormulation and preformulationCDMO management and tech transferRegulatory CMC filingsCross-functional collaboration and communication

Benefits

  • Competitive Pay
  • Stock Option Eligibility
  • 401(k) Plan
  • Open PTO Policy
  • Paid Company Holidays
  • Free lunch and snacks at our offices
  • Health Care Plan, including Medical, Dental, and Vision, fully covered for the employees
Last updated Sep 21, 2026. Interested? Apply on the company site.

About Genesis Molecular AI

The frontier AI for drug discovery

Genesis pairs frontier AI with world-class drug hunters to discover small molecule medicines. Built on Pearl and GEMS. Partnered with Gilead and Incyte.

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