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Genesis Molecular AI is seeking a Senior/Executive Director of Chemistry, Manufacturing, and Controls (CMC) to lead the strategic and technical development of a small molecule drug portfolio from candidate selection through clinical development. This role combines deep technical expertise in synthetic organic chemistry and pharmaceutical development with executive leadership of external Contract Development and Manufacturing Organizations (CDMOs).
Key Responsibilities:
- Establish and execute global CMC strategy for the small molecule discovery and development pipeline, ensuring seamless transition from lead optimization to IND/CTA enablement
- Oversee drug substance (DS) development and scale-up, including process chemistry, route scouting, crystalline form screening, polymorph evaluation, and API scale-up strategies
- Lead preformulation characterization and formulation development for drug products (DP), with focus on bioavailability optimization for challenging compounds (BCS Class II/IV) using enabling technologies such as amorphous solid dispersions, nanomilling, or lipid-based delivery systems
- Oversee analytical and QC testing strategy for DS and DP, including characterization, impurity and degradation-product control, reference standards, comparability, and stability testing
- Source, select, contract, and manage global CDMOs; monitor performance, tech transfers, and execution against milestones
- Serve as primary technical authority for global health authority interactions (FDA, EMA); author, review, and coordinate CMC modules of regulatory filings (INDs, IMPDs, CTAs, NDAs)
- Ensure adherence to phase-appropriate cGMP standards and collaborate cross-functionally with Medicinal Chemistry, Discovery Biology, DMPK, and Clinical Operations
About Genesis Molecular AI:
Genesis Molecular AI pioneers foundation models for molecular AI to unlock drug design and development. The company's GEMS platform integrates AI and physics into industry-leading models to generate and optimize drug molecules, including the breakthrough generative diffusion model Pearl for structure prediction. Backed by premier investors including a16z, NVIDIA, Rock Springs Capital, Menlo Ventures, T. Rowe Price, Fidelity, and Radical Ventures, Genesis has signed category-leading AI-pharma deals, including a significant expansion with Incyte with total potential deal value of several billion dollars. The company is headquartered in San Mateo, CA, with a fully integrated laboratory in San Diego.
Requirements:
- 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 successfully authoring and defending high-quality CMC sections for regulatory filings
- Executive presence, negotiation capabilities, and strong communication skills to translate complex technical risk in informal team settings, executive committees, and professional presentations
- Team player with strong critical thinking skills, high degree of independence, creative problem-solving abilities, enthusiasm, integrity, and adaptability to project changes
