Vice President, Technical Development

BioSpace; South San Francisco (CA); Vor Ort; USD 315.000 - 350.000; Vollzeit

Zusammenfassung

Marea Therapeutics is a South San Francisco-based clinical-stage biotechnology company advancing first-in-class cardioendocrine therapies. The Vice President, Technical Development will lead Upstream, Downstream, and Analytical Development, guiding tech transfer, scale-up, and CMC readiness for late-stage clinical development and regulatory submissions.

The role requires hands-on leadership, cross-functional collaboration, and experience translating product strategy into development plans, with

Qualifikationen

• Leadership across multi-disciplinary technical development teams.
• Cross-functional collaboration with project teams and external partners.
• Strong understanding of GMP, CMC requirements, and regulatory submissions.
• Experience managing CDMOs and external development partners.
• Experience translating product strategy into risk-balanced CMC development plans.

Aufgaben

• Provide strategic and operational leadership across Upstream/Downstream/Analytical Development.
• Oversee tech transfer, scale-up, and regulatory content for global submissions.
• Mentor function heads and teams; develop unified technical strategy.
• Manage external partners and CDMOs; ensure GMP compliance.
• Lead CMC input for INDs, BLAs, NDAs and agency interactions.

Kenntnisse

Leadership

Cross-functional collaboration

Regulatory submissions

CDMO management

Strategic planning

Ausbildung

BS/MS/PhD in Chemical Engineering or related field

Jobbeschreibung

About The Company

Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.

The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC nomination expected this year.

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results.

About The Role

Reporting to the Chief Technical Officer, the Vice President, Technical 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.

Depending on the selected candidate's breadth of experience, this role may also assume oversight of Drug Product/Formulation Development. This additional scope will be finalized based on the successful candidate's demonstrated depth across drug product and formulation development, in addition to the core scope described below.

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 RANGE

In 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.

We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans, and all other qualified applicants.