Vice President, CMC at Aditum Bio

Aditum Bio is seeking a Vice President of CMC to lead the planning, oversight, and execution of CMC operations for assigned portfolio companies. This role is responsible for strategic planning with portfolio companies and the Board of Directors, as well as executing plans with strategic partners and Contract Manufacturers. The VP of CMC will collaborate with Portfolio Companies to closely plan CMC programs (drug substance and drug product manufacturing and analytical activities), from preclinical development through clinical supplies for Phase 3 registration studies.

• Develop CMC Strategy and Planning
• Build the organization to deliver quality systems and operations
• Oversee partner and vendor relationships and activities
• Ensure program execution and oversight

Requirements:

• PhD/MS in science (e.g., organic chemistry, chemistry, pharmaceutical sciences, or related discipline)
• Pharmaceutical/biotechnology industry experience (minimum 10 years) in managing US and International CRO/CMOs for the manufacture of non GMP and cGMP APIs and DP
• Experience with projects preclinical through Phase 3 including multiple dosage forms (e.g., tablets, capsules, topicals, parenteral formulations etc) and multiple molecule types (e.g., small and large molecule; biologics experience a plus)
• Strong leadership skills with ability to be hands-on and lead/manage the CMC programs
• Thorough knowledge of cGMP manufacturing and IND, CTA and NDA filings; thorough and relevant knowledge of FDA and EMA regulations
• Strong skills in identifying and resolving critical issues
• Strong track record in effectively working with senior management

Aditum Bio Offers:

• Equity compensation
• Medical, dental, vision, disability, life, and 401k plan with match
• Flexible/non-accrued PTO plus 12 paid holidays