Senior Director, Formulation and Drug Product Development at Marea Therapeutics Inc

Description

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. The company is led by a dynamic team of scientists and company builders with deep knowledge and experience in cardioendocrine diseases, human genetics, and adipocyte biology.  

At Marea, we believe in the power of collaboration and the importance of leading by example. We are a tight-knit team that values the contributions of every member, from interns to senior leaders. Our environment is dynamic, with each day presenting new challenges and opportunities for growth. Every role is “Hands-On”, and the successful candidate will be able to work alongside team members, regardless of level, to understand challenges and drive results. 

ABOUT THE ROLE

This is a key role within the first phase of hiring for our Technical Operations team as we aggressively advance the first program towards late-stage development and our second program into early-stage clinical 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.   Successful candidate will develop CMC strategy for formulation and drug product working cross functionally across other technical operations functions and also 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. Ina addition to the strategic responsibilities, candidate will have operational responsibility to provide technical and day-to-day oversight of our CDMOs and other external partners conducting the work.  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.

Requirements

·  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 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

·  Plan design of process characterization and validation studies leading upto 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.