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

Genesis Molecular AI

San Diego, CA Full-time Posted 3w ago
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The Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC) will serve as the strategic and technical leader managing a small molecule portfolio development from candidate selection through clinical development. Operating within a lean, agile mindset, this executive will manage a robust external network of CDMOs to drive drug substance (DS) synthesis, process chemistry optimization, scale-up, and advanced formulation/drug product (DP) development. The ideal candidate blends deep synthetic organic chemistry and preformulation expertise with the strategic vision required to navigate rapid timelines, risk management and global regulatory frameworks. The candidate will be expected to be a CMC leader possessing strong communication skills What You Will Do: * 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 (e.g., BCS Class II/IV compounds) 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 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. What you’ll bring: * 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 drug substance (DS) and drug product (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 effectively translate complex technical risk in informal team settings, executive committees and professional presentations. * Motivated team player with strong critical thinking skills, a high degree of independence, strong creative problem-solving skills, enthusiasm, integrity and ability to adapt to project changes. What we offer: * 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 About Genesis Molecular AI Genesis Molecular AI is pioneering foundation models for molecular AI to unlock a new era of drug design and development. Our generative and predictive AI platform, GEMS (Genesis Exploration of Molecular Space), integrates AI and physics into industry-leading models to generate and optimize drug molecules, including the breakthrough generative diffusion model Pearl for structure prediction. Genesis is backed by premier AI and life science investors, including a16z, NVIDIA, Rock Springs Capital, Menlo Ventures, T. Rowe Price, Fidelity, and Radical Ventures. Genesis has also signed category-leading AI-pharma deals, the most recent of which was a significant expansion with Incyte (see coverage in Forbes and GEN) with a total potential deal value of several billion dollars. Genesis is headquartered in San Mateo, CA, with a fully integrated laboratory in San Diego. We are proud to be an inclusive workplace and an Equal Opportunity Employer.

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