CMC Lead Role

We are seeking a highly experienced CMC Lead to spearhead the strategy and operations for drug and combination products within our innovative startup. This role involves coordinating formulation, analytics, and manufacturing processes while ensuring compliance with regulatory standards.

Key Responsibilities

• Lead CMC strategy and operations for drug and combination products.
• Coordinate formulation, analytics, and manufacturing with the device component.
• Oversee outsourcing with CDMOs and set acceptance criteria.
• Manage analytical method development, validation, and stability testing.
• Define comparability strategies for clinical and commercial lots.
• Ensure compliance with cGMP and readiness for regulatory inspections.

Requirements & Qualifications

• Advanced degree (Ph.D. preferred) in Pharmaceutical Sciences, Chemistry, or a related field.
• 10+ years of drug development experience with leadership in CMC strategy.
• Expertise in formulation development and analytical method development/validation.
• Strong knowledge of FDA regulations, GMP, and global regulatory requirements.
• Experience in scaling products from early clinical to commercial manufacturing.
• Exceptional leadership and communication abilities.