Senior Executive Director of Chemistry Manufacturing and Controls
AI-focused biotechnology company developing molecular-AI systems and small-molecule drug candidates for internal programs and pharmaceutical partners.
Funding history
About Genesis Molecular AI
Genesis Molecular AI combines foundation models, generative and predictive AI, and physics-based computation in its GEMS platform for small- and medium-size-molecule drug discovery.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead global CMC strategy for small-molecule programs from candidate selection through clinical development. You will oversee drug-substance and drug-product development, analytical and QC strategy, CDMO relationships, regulatory filings, cGMP compliance, and cross-functional planning for clinical material supply.
Requirements
- PhD with at least 12 years of industrial CMC experience or MS with at least 16 years of industrial CMC experience
- Expertise in API synthetic pathway optimization and oral solid-dose formulation
- Experience leading analytical development and QC through external CDMOs
- Experience in method development, transfer, troubleshooting, and validation
- Knowledge of cGMP operations, global regulatory expectations, and ICH guidance
- Experience authoring and defending CMC regulatory filing sections
- Negotiation and communication skills
Responsibilities
- Establish and execute global CMC strategy for the small-molecule pipeline
- Oversee process chemistry, route scouting, form screening, and API scale-up
- Lead preformulation characterization and drug-product formulation development
- Oversee analytical strategy, QC testing, and data review
- Source, contract, and direct CDMOs
- Lead CMC regulatory strategy and coordinate regulatory filings
- Partner with medicinal chemistry, biology, DMPK, and clinical operations
Benefits
- Stock option eligibility
- 401(k) plan
- Open PTO policy
- Paid company holidays
- Free office lunch and snacks
- Medical insurance fully covered for employees
- Dental insurance fully covered for employees
- Vision insurance fully covered for employees