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