Senior CMC Director: Small Molecule Development

Genesis Molecular AI; San Diego (CA); Sur place; USD 250 000 - 400 000; Plein temps

Avantages offerts par ce poste

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, D

Résumé du poste

Genesis Molecular AI seeks a Senior/Executive Director of Chemistry, Manufacturing, and Controls (CMC) to lead a small molecule portfolio from candidate selection through clinical development. The role oversees DS synthesis, scale-up, DP formulation, regulatory filings, and CDMO partnerships, aligning with global regulatory standards and fast-paced timelines.

The candidate will bring deep synthetic organic chemistry expertise, preformulation know-how, and excellent communication skills to manage

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
• MS in Synthetic Organic chemistry, Chemical Engineering, Analytical chemistry, Pharmaceuticals or closely related scientific disciplines with at least 16 years of industrial CMC experience

Responsabilités

• 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 APIs
• Formulation & Drug Product (DP) Design: Lead preformulation characterization and formulation development to maximize bioavailability for challenging compounds using enabling technologies
• 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
• CDMO Management: Source, select, contract (MSA/SOW) and direct global CDMOs; monitor performance and tech transfers
• Regulatory Strategy & Compliance: Act as primary technical authority for global health authority interactions (FDA, EMA); coordinate CMC modules for filings
• Cross-Functional Collaboration: Partner with Medicinal Chemistry, DMPK, Clinical Operations to ensure developability and supply chains

Connaissances

Executive presence

Negotiation

Communication skills

Team player

Critical thinking

Problem solving

Independence

Adaptability

Formation

PhD in Synthetic Organic chemistry (or related)

MS in Synthetic Organic chemistry (or related)

Description du poste

Genesis Molecular AI seeks a Senior/Executive Director of Chemistry, Manufacturing, and Controls (CMC) to lead a small molecule portfolio from candidate selection through clinical development. The role oversees DS synthesis, scale-up, DP formulation, regulatory filings, and CDMO partnerships, aligning with global regulatory standards and fast-paced timelines.

The candidate will bring deep synthetic organic chemistry expertise, preformulation know-how, and excellent communication skills to manage