Executive Director, Formulation and Drug Product Development

Executive Director, Formulation and Drug Product Development Apply for the Executive Director, Formulation and Drug Product Development role at Marea Therapeutics 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 therapies and serve as transformative treatment 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 now 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 towards clinical development acromegaly. Marea is a fast-growing company looking for extraordinary individuals to join our team who want to make a difference in the lives of millions of people living with cardioendocrine diseases. About the Role Key responsibilities: oversee formulation development, drug product development and manufacturing, transition from vials to prefilled syringe across all development programs; develop CMC strategy; collaborate with cross-functional teams; manage CDMOs; lead tech transfer and manufacturing; contribute to CMC life cycle; provide molecular and formulability assessment; drive product comparability and analytical characterization. Key Responsibilities Accountable for formulation and drug product development strategy and execution for the Marea portfolio Develop a holistic drug product, formulation and device strategy for each asset Design and execute pre-formulation and formulation studies with a focus on stability, manufacturability, and patient-centric delivery Develop scalable drug product processes; lead scale-up and tech transfer to CDMOs; provide technical oversight of CDMO operations Drive development of combination products, including pre-filled syringes; experience with autoinjectors is a strong plus Author and review CMC sections of regulatory documents (INDs, IMPDs, and BLAs) Partner closely with internal stakeholders (Analytical, Process Development, Quality, Regulatory, Clinical) to ensure cross-functional alignment Manage external partners (CDMOs, CROs) to execute formulation and fill-finish activities, including oversight of timelines, budgets, and technical deliverables Identify, plan, and complete product and container compatibility, leachables and extractables studies necessary 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 manufacturing 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 related field 15+ years 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, prefilled syringe (autoinjector familiarity 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 per year Working Conditions The role may need to occasionally work in laboratory environment Travel to CDMOs/CTOs may be needed up to 10% of the time 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 Marea Therapeutics