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

Location: San Diego, California, United States; on-site

Company

Develops foundation models for molecular AI and an integrated platform for generating and optimizing drug molecules.

What you will do

• Establish and execute the global CMC strategy for a small-molecule discovery and development pipeline from lead optimization through IND/CTA enablement.
• Lead drug substance development, including route scouting, process chemistry optimization, crystalline form and polymorph evaluation, and API scale-up.
• Direct preformulation and drug product development for oral solid dosage forms, including bioavailability-enhancing approaches for BCS Class II/IV compounds.
• Oversee analytical strategy, impurity and degradation-product control, reference standards, comparability, stability, QC testing, and data review.
• Source, contract, and manage global CDMOs, including negotiations, technology transfers, milestone execution, and issue resolution.
• Serve as the technical authority for FDA and EMA interactions and coordinate CMC sections for INDs, IMPDs, CTAs, and future NDAs.

Requirements

• PhD in synthetic organic chemistry, chemical engineering, analytical chemistry, pharmaceuticals, or a related discipline with at least 12 years of industrial CMC experience, or an MS with at least 16 years of experience.
• Deep expertise in API synthetic pathway optimization and modern formulation methods for oral solid dosage forms.
• Experience leading analytical development and QC activities through external CDMOs across multiple programs and partners.
• Hands-on experience with method development, transfer, troubleshooting, and validation for small-molecule drug substance and drug product.
• Strong knowledge of cGMP laboratory operations, global regulatory expectations, ICH guidance, and CMC regulatory filings.
• Executive presence, negotiation skills, strong communication, critical thinking, independence, and creative problem-solving ability.

Culture & Benefits

• Lean and agile working environment with cross-functional collaboration across medicinal chemistry, discovery biology, DMPK, and clinical operations.
• Competitive pay and stock option eligibility.
• 401(k) plan and fully covered medical, dental, and vision care for employees.
• Open PTO policy and paid company holidays.
• Free lunch and snacks at the offices.