BioSpace
Executive Director, Formulations and Drug Product Development
BioSpace, South San Francisco, California, us, 94083
Executive Director, Formulations and Drug Product Development
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.
Job Type: Full‑time
About The Role This key role within the Technical Operations team will report to the CTO and is responsible for overseeing formulation development, drug product development, and manufacturing for all Marea development programs. The successful candidate will develop CMC strategy for formulation and drug product, working cross‑functionally across other technical operations functions and closely with clinical development, clinical operations, and program teams to ensure the product profile and configuration are consistent with the target profile required for clinical studies and eventual commercial launch. The role also involves providing day‑to‑day oversight of CDMOs and external partners, making critical technical decisions around formulation selection and drug product presentations for the entire portfolio, planning future tech transfer and manufacturing strategies, and developing and executing life‑cycle plans integrated with the cross‑functional project team and financial operating plans.
Requirements 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 Marea asset, considering clinical/patient experience, commercial opportunity, and regulatory requirements.
Design and execute pre‑formulation and formulation studies (with external CDMO partners), focusing 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, 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, overseeing timelines, budgets, and technical deliverables.
Identify, plan, and complete necessary product and container compatibility, leachables, and extractables studies required for regulatory submission stages.
Contribute strategically and scientifically to CMC planning and risk mitigation across programs.
Be hands‑on when needed and adapt 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.
Strong knowledge of various drug product configurations, including vials and pre‑filled 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 The salary range for this role is $275,000 – $315,000. Compensation and title will be competitive and commensurate with the candidate’s experience, qualifications, and responsibilities.
Working Conditions
The role may require occasional work in a laboratory environment.
Travel to CDMOs/CTOs may be needed up to 10% of the time (variable, with some 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.
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Job Type: Full‑time
About The Role This key role within the Technical Operations team will report to the CTO and is responsible for overseeing formulation development, drug product development, and manufacturing for all Marea development programs. The successful candidate will develop CMC strategy for formulation and drug product, working cross‑functionally across other technical operations functions and closely with clinical development, clinical operations, and program teams to ensure the product profile and configuration are consistent with the target profile required for clinical studies and eventual commercial launch. The role also involves providing day‑to‑day oversight of CDMOs and external partners, making critical technical decisions around formulation selection and drug product presentations for the entire portfolio, planning future tech transfer and manufacturing strategies, and developing and executing life‑cycle plans integrated with the cross‑functional project team and financial operating plans.
Requirements 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 Marea asset, considering clinical/patient experience, commercial opportunity, and regulatory requirements.
Design and execute pre‑formulation and formulation studies (with external CDMO partners), focusing 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, 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, overseeing timelines, budgets, and technical deliverables.
Identify, plan, and complete necessary product and container compatibility, leachables, and extractables studies required for regulatory submission stages.
Contribute strategically and scientifically to CMC planning and risk mitigation across programs.
Be hands‑on when needed and adapt 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.
Strong knowledge of various drug product configurations, including vials and pre‑filled 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 The salary range for this role is $275,000 – $315,000. Compensation and title will be competitive and commensurate with the candidate’s experience, qualifications, and responsibilities.
Working Conditions
The role may require occasional work in a laboratory environment.
Travel to CDMOs/CTOs may be needed up to 10% of the time (variable, with some 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.
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