Responsibilities

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.

Senior / Executive Director of Chemistry, Manufacturing, and Controls (CMC) at Genesis Molecular AI · LumiJobs

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

Responsibilities

Qualification

Required

Benefits

Company

Genesis Molecular AI

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