Executive Director, Formulations and Drug Product Development

Executive Director, Formulations and Drug Product Development About the Company Marea Therapeutics is a clinical-stage biotechnology company based in San Francisco with a growing pipeline of first‑in‑class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to complement existing treatments and serve as transformative options for significant patient populations living with cardioendocrine diseases. Incubated by Third Rock Ventures, Marea completed a Series B financing in June 2024 and is well‑funded by a syndicate of life science investors, including Sofinnova, Forbion, Perceptive Advisors, Xontogeny, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures. The company’s lead program is in Phase 2 clinical development (MAR001) and a second program is progressing toward clinical development in acromegaly. Marea is a fast‑growing company seeking extraordinary individuals who want to make a difference in the lives of millions of people living with cardioendocrine diseases. The company is led by a dynamic team of scientists and company builders with deep knowledge in cardioendocrine diseases, human genetics, and adipocyte biology. About the Role This is a key role within the first phase of hiring for our Technical Operations team. The role reports to the CTO and will oversee formulation development, drug product development and manufacturing, and the transition from vials to prefilled syringes for all of Marea’s development programs. The successful candidate will develop a CMC strategy for formulation and drug product, work cross‑functionally with technical operations, clinical development, clinical operations and program teams to ensure the product profile aligns with the target profile for clinical study and eventual commercial launch. The role also includes operational oversight of CDMOs and external partners, strategic tech transfer and drug product manufacturing planning, life‑cycle strategy, and alignment with financial operating plans. Key Responsibilities Accountable for formulation and drug product development strategy and execution for the entire Marea portfolio, including monoclonal antibodies in early and late‑stage CMC development and other modalities in discovery. Develop a holistic drug product, formulation, and device strategy for each asset, considering clinical/patient experience, commercial opportunity, and regulatory requirements. Design and execute, with external CDMO partners, pre‑formulation and formulation studies focused on stability, manufacturability, and patient‑centric delivery. Develop scalable drug product processes for all formulations; lead scale‑up and tech transfer to CDMOs and provide technical oversight of CDMO operations. Drive development of combination products, including pre‑filled syringes; experience with autoinjectors is a strong plus. Author or review CMC sections of regulatory documents (e.g., INDs, IMPDs, and BLAs). Partner closely with internal stakeholders (Analytical, Process Development, Quality, Regulatory, Clinical) to ensure cross‑functional alignment of key formulation and drug product assumptions. Manage external partners (CDMOs, CROs) to execute formulation and fill‑finish activities, overseeing timelines, budgets, and technical deliverables. Identify, plan, and complete necessary product and container compatibility, leachables, and extractables studies required for the stage of the regulatory submission. Contribute strategically and scientifically to CMC planning and risk mitigation across programs. Be hands‑on where needed and adaptable to the evolving needs of a dynamic startup environment. Oversee tech transfer and manufacturing of drug product at CDMOs. Lead and deliver process characterization and validation studies leading up to the BLA, including other BLA‑enabling activities related to drug product and formulation. Collaborate with discovery teams for early molecular and formulability assessment to guide selection of future drug candidates. Identify and generate drug product comparability and analytical characterization as part of the CMC life‑cycle management. Key Qualifications PhD or MS in Pharmaceutics, Biochemistry, Chemical/Biomedical Engineering, or a related field. 15+ years (PhD) of relevant industry experience in formulation and drug product development of biologics. Deep understanding of protein formulation principles, stability challenges, and container/closure compatibility. Solid understanding of various drug product configurations, including vials and prefilled syringes (autoinjector familiarity is a plus). Experience in early‑phase development (preclinical/IND) with strong knowledge of regulatory expectations; late‑stage/BLA experience is a plus. Demonstrated success working in fast‑paced, resource‑constrained environments with a solutions‑first mindset. Strong communication skills and ability to work across disciplines and with external partners. Comfortable wearing multiple hats and contributing both strategically and tactically. Pay Range $275,000 - $315,000. Compensation and title will be competitive and commensurate with the candidate’s experience, qualifications, and responsibilities. Working Conditions Role may require occasional work in a laboratory environment. Travel to CDMOs/CTLs may be needed up to 10% of the time, variable with peak windows. 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. #J-18808-Ljbffr