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Character Biosciences · 3 months ago

VP, CMC & Technical Operations

San Francisco Office

Full-time

Onsite

Director/Executive

12+ years exp

Character Biosciences is a precision medicine company pioneering targeted therapies for polygenic diseases, focusing initially on ophthalmology. The VP of CMC & Technical Operations will lead all Chemistry, Manufacturing, and Controls activities, driving strategy and execution for early development and clinical supply.

Artificial Intelligence (AI)BiotechnologyClinical TrialsHealth CareHealth DiagnosticsTherapeutics

Responsibilities

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

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

Collaborate with Quality to establish and maintain phase-appropriate quality systems

Ensure regulatory compliance with evolving clinical-stage requirements

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

Qualification

CMC developmentIND/IMPD submissionsGMP manufacturingBiopharma experienceProcess developmentEntrepreneurial mindsetLeadershipCollaboration

Required

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