ABOUT THE ROLEReporting to the Chief Technical Officer, the Vice President, Bioprocess and Analytical Development will provide strategic and operational leadership across Marea's core Technical Development functions - Upstream Process Development, Downstream Process Development, and Analytical Development - through late-stage clinical development. This role will lead and develop the function heads and teams within these three areas, set unified technical strategy across drug substance development, and execute development, tech transfer, scale up and ensure CMC readiness for late stage clinical development and regulatory submissions.
An ideal candidate is a blend of strong technical foundation in the functional disciplines they will oversee, demonstrated experience of having successfully completed development through early and late stages of CMC development, strong cross-functional collaborative skills, experience in translating product strategy into risk-balanced CMC development plan and a hands-on leadership approach.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIES- Provide strategic and operational leadership across the Upstream Process Development, Downstream Process Development, and Analytical Development functions
- Working with CDMO and external partners, ensure delivery of all work packages covering process, analytical development, tech transfer, scale up, technical content for global regulatory submissions
- Lead, mentor, and develop the function heads and teams responsible for each of these areas
- Develop and execute an integrated technical development strategy that is synchronized with the cross functional project team's plans and translated into executable SOWs with external partners
- Lead technical development from IND-enabling stages through late-stage clinical development
- Provide strategic input to portfolio planning, development timelines, and investment decisions
- Oversee upstream and downstream process development, characterization, scale-up, and technology transfer activities
- Ensure development of scalable, cost-effective, and compliant manufacturing processes
- Direct analytical method development, qualification, validation, and comparability strategy across programs
- Manage external manufacturing organizations and technical service providers supporting upstream, downstream, and analytical activities
- Provide CMC leadership for regulatory submissions, including INDs, BLAs, NDAs, and other global filings, with particular focus on upcoming IND/BLA-enabling agency interactions for Marea's pipeline
- Author and review CMC sections of regulatory documents within the function's scope
- Support agency interactions related to manufacturing, process development, and product quality
- Partner with Quality Assurance to maintain GMP compliance across all development and manufacturing activities within scope
- Support inspection readiness and responses to regulatory observations
- Partner closely with Manufacturing, Supply Chain, Regulatory Affairs, and Clinical Development to ensure alignment across the broader technical operations organization
- Oversee budgets and build, mentor, and retain a high-performing technical development organization
- If Drug Product/Formulation Development is added to scope: oversee formulation development, drug product process development, and related CDMO relationships
- Actively participate in cross functional CMC and Project teams and guide strategies and plans
QUALIFICATIONS- BS, MS, or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Chemistry, or a related field; a Ph.D. is not required but is highly desirable
- 15-20 years of biotechnology or pharmaceutical industry experience
- Significant leadership experience across two or more of: Upstream Process Development, Downstream Process Development, Analytical Development, or Drug Product/Formulation Development
- Demonstrated success advancing products from early development through late-stage clinical development
- Strong understanding of GMP regulations, CMC requirements, and regulatory submissions
- Experience managing CDMOs and external development partners
- Experience building, leading, and mentoring multi-disciplinary technical development teams
- Demonstrated skills in working cross functionally (example, prior experience as a CMC team lead for a late stage product is a plus)
- Drug Product/Formulation development experience is a significant plus and may expand the scope of this role
PAY RANGEIn compliance with applicable pay transparency laws, the expected base salary range for this position is $315,000 to $350,000 annually. This range represents the Company's good faith estimate of the salary range for this role at the date of hire and is subject to change.
WORKING CONDITIONS - Up to 10% travel required with occasional peak travel windows
- Three days on-site at the Marea office required.
