Marea Therapeutics
Senior Director, Formulation and Drug Product Development
Marea Therapeutics, South San Francisco, California, us, 94083
Senior Director, Formulation and Drug Product Development
This role will initially report to the CTO. The successful candidate will oversee formulation development, drug product development and manufacturing, transition from vials to prefilled syringe for all of Marea’s development programs. The role will develop CMC strategy for formulation and drug product, work cross‑functionally with other technical operations functions and work closely with clinical development, clinical operations and program teams to ensure that the product profile and configuration is consistent with the target profile needed for the clinical study. In addition to the strategic responsibilities, the candidate will have operational responsibility to provide technical and day‑to‑day oversight of our CDMOs and other external partners conducting the work. The candidate will also plan future tech transfer and drug product manufacturing strategy, identify life‑cycle plans and ensure these are integrated into the cross‑functional project team as well as the financial operating plans.
Base pay range $236,000.00/yr - $270,500.00/yr
Key Responsibilities
Lead formulation and drug product development strategy for monoclonal antibodies in the portfolio that spans early and late‑stage CMC development
Design and execute (working with the external CDMO partner) pre‑formulation and formulation studies with a focus on stability, manufacturability, and patient‑centric delivery
Develop scalable drug product processes for liquid formulations; support scale‑up and tech transfer to CDMOs. Provide technical oversight of the operations at the CDMOs
Drive development of combination products, including pre‑filled syringes; experience with autoinjectors is a strong plus
Author and review CMC sections of regulatory submissions including INDs, IMPDs, and BLAs
Partner closely with internal stakeholders (Analytical, Process Development, Quality, Regulatory, Clinical) to ensure cross‑functional alignment of key assumptions around formulation and drug product
Manage external partners (CDMOs, CROs) to execute formulation and fill‑finish activities, including oversight of timelines, budgets, and technical deliverables.
Identify, plan and complete necessary product and container compatibility, leachables and extractable 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
Plan design of process characterization and validation studies leading up to the BLA
Key Qualifications
PhD or MS in Pharmaceutical Science, Biochemistry, Chemical/Biomedical Engineering, or related field
12 plus years (PhD) or 15+ years (MS) 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.
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Base pay range $236,000.00/yr - $270,500.00/yr
Key Responsibilities
Lead formulation and drug product development strategy for monoclonal antibodies in the portfolio that spans early and late‑stage CMC development
Design and execute (working with the external CDMO partner) pre‑formulation and formulation studies with a focus on stability, manufacturability, and patient‑centric delivery
Develop scalable drug product processes for liquid formulations; support scale‑up and tech transfer to CDMOs. Provide technical oversight of the operations at the CDMOs
Drive development of combination products, including pre‑filled syringes; experience with autoinjectors is a strong plus
Author and review CMC sections of regulatory submissions including INDs, IMPDs, and BLAs
Partner closely with internal stakeholders (Analytical, Process Development, Quality, Regulatory, Clinical) to ensure cross‑functional alignment of key assumptions around formulation and drug product
Manage external partners (CDMOs, CROs) to execute formulation and fill‑finish activities, including oversight of timelines, budgets, and technical deliverables.
Identify, plan and complete necessary product and container compatibility, leachables and extractable 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
Plan design of process characterization and validation studies leading up to the BLA
Key Qualifications
PhD or MS in Pharmaceutical Science, Biochemistry, Chemical/Biomedical Engineering, or related field
12 plus years (PhD) or 15+ years (MS) 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.
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