Marea Therapeutics · 1 month ago
Executive Director, Formulations and Drug Product Development
South San Francisco, CA
Full-time
Onsite
Director/Executive
$275K/yr - $315K/yr
15+ years expMarea Therapeutics is a clinical-stage biotechnology company based in San Francisco focused on developing first-in-class therapies for cardioendocrine diseases. The Executive Director will oversee formulation development and drug product manufacturing, ensuring alignment with clinical and commercial goals while managing external partners and leading CMC strategy.
BiotechnologyGeneticsLife Science
Responsibilities
Accountable for formulation and drug product development strategy and execution for the entire Marea portfolio which includes 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 of Marea’s asset keeping in mind clinical/patient experience, commercial opportunity and regulatory considerations
Design/execute (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 all formulations; lead 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/review CMC sections of regulatory document (ex., 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 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 upto 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
Qualification
Required
PhD or MS in Pharmaceutics, Biochemistry, Chemical/Biomedical Engineering, or related field
15+ plus 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, 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
Preferred
Experience with autoinjectors is a strong plus
Late-stage/BLA experience is a plus
Company
Marea Therapeutics
Marea is a biotechnology company that develops therapies and medications for the treatment of cardioendocrine illness patients.
11-50 employees
Funding
Current Stage
Growth StageTotal Funding
$255.42MKey Investors
Third Rock Ventures
2024-06-18Series B· $190M
2024-06-18Series A· $65.42M
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