CMC Executive: Small Molecule DS/DP & CDMO Strategy

Genesis Therapeutics; San Diego (CA); On-site; USD 300,000 - 520,000; Full time

Benefits offered by this job

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

ental and Vision, fully covered for th

Job summary

Genesis Molecular AI seeks an Senior/Executive Director of Chemistry, Manufacturing, and Controls (CMC) to lead a small molecule portfolio from candidate selection through clinical development. The role emphasizes strategic leadership, external CDMO governance, and regulatory interaction to navigate timelines and risk.

The ideal candidate combines deep synthetic organic chemistry and preformulation expertise with executive communication and global regulatory insight to drive DS synthesis,

Qualifications

• PhD with 12+ years industrial CMC experience OR MS with 16+ years industrial CMC experience.
• Deep technical competence in API synthesis and modern drug product formulation.
• Experience leading Analytical Development and QC via external CDMOs.
• Hands-on method development, transfer, troubleshooting, and validation for DS/DP.
• Strong knowledge of cGMP, regulatory expectations and ICH guidance.
• Proven authoring/defending CMC sections for regulatory filings.

Responsibilities

• Establish and execute the global CMC strategy from lead optimization to IND/CTA enablement.
• Oversee DS development, scale-up, route scouting, and crystallinity screening.
• Lead DP design, preformulation, and formulation to maximize bioavailability.
• Oversee analytical strategy, QC testing, impurity control, and stability.
• Source, select, contract CDMOs, and manage tech transfers and milestones.
• Coordinate regulatory filings and ensure phase-appropriate cGMP compliance.
• Collaborate with cross-functional teams to ensure developability early.

Skills

Strategic leadership

Executive communication

Cross-functional collaboration

Regulatory strategy

Risk management

Education

PhD in Synthetic Organic Chemistry or related field

MS in Synthetic Organic Chemistry or related field

Job description

Genesis Molecular AI seeks an Senior/Executive Director of Chemistry, Manufacturing, and Controls (CMC) to lead a small molecule portfolio from candidate selection through clinical development. The role emphasizes strategic leadership, external CDMO governance, and regulatory interaction to navigate timelines and risk.

The ideal candidate combines deep synthetic organic chemistry and preformulation expertise with executive communication and global regulatory insight to drive DS synthesis,