VP, CMC

The VP of CMC & Technical Operations will lead all Chemistry, Manufacturing, and Controls (CMC) activities at Character, with a current focus on early development and clinical supply. This leader will drive process and analytical development, regulatory CMC strategy, and CDMO oversight to enable IND/IMPD filings and ensure reliable supply for Phase 1-3 clinical trials. Operating in a lean biotech environment, the VP will combine strategic leadership with hands-on execution.

• CMC Strategy & Development
• Serve as the company's subject matter expert for CMC, providing guidance to development teams, executive leadership and the board.
• Define and implement CMC strategy across drug substance, drug product, and analytical sciences.
• Lead IND/IMPD CMC authoring and regulatory interactions.
• Develop and execute efficient and timely clinical supply chain.
• Collaborate with clinical operations to ensure CMC plans support rapid entry into first-in-human and proof-of-concept studies.
• Anticipate and mitigate manufacturing and supply risks in a resource-efficient way.
• Manufacturing & Supply
• Oversee CDMO selection and management for GMP manufacturing.
• Direct tech transfer of processes into external manufacturing sites.
• Ensure timely supply of clinical trial materials and stability testing.
• Quality & Compliance
• Collaborate with Quality to establish and maintain phase-appropriate quality systems.
• Ensure regulatory compliance with evolving clinical-stage requirements.
• Leadership & Collaboration
• Partner closely with clinical, regulatory, and nonclinical functions to align CMC deliverables with program timelines.
• Represent CMC/Operations at the executive level and with external stakeholders.

• Advanced degree (PhD, MS, or equivalent) in chemistry, biochemistry, engineering, or related field.
• 12+ years of biopharma experience with strong expertise in biopharma CMC development including leadership roles in process development, manufacturing, and regulatory CMC.
• Proven track record of taking programs from early through late stage development and commercial launch.
• Successful track record supporting IND/IMPD submissions and early clinical trial supply.
• Hands-on experience with CDMO management and GMP manufacturing for clinical programs.
• Entrepreneurial, execution-focused mindset suitable for a lean biotech environment.