Related skills
validation cmc analytical method development fda regulations formulation development📋 Description
- Define and execute the CMC development strategy for trials
- Support outsourced CDMO work on drug substance/product and device compatibility
- Establish critical quality attributes and acceptance criteria
- Lead analytical method development, validation, and lifecycle management
- Interface with CDMOs, CROs, and suppliers; manage timelines and risks
- Prepare IND submissions and NDA modules; support FDA meetings
🎯 Requirements
- Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences or related field
- 10+ years of drug development with leadership of CMC strategy
- Formulation development, analytical method development/validation, stability, GMP
- Strong knowledge of FDA regulations, GMP guidelines, and global regulatory requirements
- Track record supporting INDs and/or NDAs
- Ability to operate independently in a fast-paced startup
🎁 Benefits
- Opportunity to shape CMC strategy for an innovative combination product
- High-impact role with direct access to leadership and decision-making
- Collaborative, mission-driven team
- Flexibility in working style and scope
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