Related skills
validation gmp cmc analytical method development formulation development📋 Description
- Lead CMC strategy and operations for drug and combination products.
- Coordinate formulation, analytics, and manufacturing with the device component.
- Oversee outsourcing with CDMOs; set acceptance criteria.
- Manage analytical method development, validation, and stability testing.
- Define comparability strategies for clinical and commercial lots.
- Ensure cGMP and readiness for regulatory inspections.
🎯 Requirements
- Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, or related field.
- 10+ years of drug development with leadership of CMC strategy.
- Expertise in formulation development, analytical method development/validation, stability.
- Strong knowledge of FDA regulations, GMP, and global regulatory requirements.
- Experience scaling products from early clinical to commercial manufacturing.
- Exceptional leadership and communication abilities.
🎁 Benefits
- Opportunities to shape drug development at a groundbreaking startup.
- Competitive compensation and equity options.
- Collaborative, mission-driven culture.
- Growth opportunities as the company advances through clinical stages.
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