VP, CMC & Technical Operations

VP, CMC & Technical Operations

About Character Biosciences

Character Biosciences is a precision medicine company pioneering targeted therapies for polygenic diseases, with an initial focus on ophthalmology. Our patient data platform integrates genomics with deep, longitudinal clinical and imaging data, enabling us to uncover genetic drivers of disease progression, advance novel therapeutics, and define patient stratification strategies that improve clinical success.

Our interdisciplinary team spans human genetics, clinical science, data science and engineering, and drug discovery and development. We are advancing two programs for Dry Age-related Macular Degeneration (AMD) into the clinic, with additional discovery-stage programs underway.

Founded in 2018, Character has raised capital from leading investors at the intersection of healthcare and technology, including an oversubscribed $93 million Series B in March 2025 co-led by aMoon and Luma Group, with participation from Bausch + Lomb, Innovation Endeavors, Catalio Capital Management, S32, KdT Ventures, and Jefferson Life Sciences. We also maintain a multi-target drug discovery collaboration with Bausch + Lomb to develop innovative precision medicines for AMD.

The Opportunity

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.

Key Responsibilities

• 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.
  

Required Qualifications/ Experience

• 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.