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
Genesis is headquartered in San Mateo, CA, with a fully integrated laboratory in San Diego.
