Marea Therapeutics
Executive Director, Formulation and Drug Product Development
Marea Therapeutics, South San Francisco, California, us, 94083
Executive Director, Formulation and Drug Product Development
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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.
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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