Senior/Executive Director, Analytical Development
ABOUT THE COMPANY
Marea Therapeutics is a clinical-stage biotechnology company based in South 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 well funded by a syndicate of leading life science investors including Sofinnova, Forbion, Xontogeny/ Perceptive Advisors, venBio, Omega Funds, Surveyor, Alpha Wave and Third Rock Ventures.
The company’s lead program, MAR001, is a monoclonal antibody targeting ANGPTL4, a genetically validated target with potential to address the subset of patients at the highest risk of adverse cardiovascular events, despite current standard of care therapies. MAR001 is rapidly progressing through Phase 2b clinical development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is rapidly progressing through Phase 1 clinical development. We also have a third asset that is rapidly advancing through research discovery, with DC nomination expected next year.
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
The Senior/Executive Director of Analytical Development will be both the strategic head and technical driver of analytical development across Marea’s pipeline. This individual will set the vision for analytical sciences while also remaining engaged in the detailed design, execution, and troubleshooting of methods. This is a key role 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 be a working leader: equally comfortable shaping analytical strategy suitable for major submissions, presenting to authorities, and at the same time being hands-on reviewing data packages, troubleshooting methods with the team and partners. The successful candidate will have strong technical background in developing, qualifying and transferring necessary in-process, release and characterization methods to support development of all monoclonal antibody programs at Marea. The candidate will work closely with other members of the technical operations team including process development, manufacturing, QC and QA, and CMC regulatory as well as cross-functionally with research and clinical team to support the larger program goals. Ideal candidate will offer a mix of strong technical skills in monoclonal antibody in method development, hands-on laboratory development experience, experience working with CDMOs and CTLs and ability to develop strong written technical data packages that are phase appropriate and of high quality expected in regulatory submissions. Candidate needs to have demonstrated experience or minimally basic familiarity in various physicochemical methods (chromatographic, electrophoretic, peptide mapping), biochemical assays, functional assays, impurity and residual testing, stability and degradation studies to support the overall product release, process control, product characterization, process improvements, comparability assessments and regulatory submissions. Familiarity or experience in bioassay development will be very desirable. Ideal candidate will have primary experience in multiple molecular modalities with primary focus on monoclonal antibodies as wells as siRNA lipid conjugate based drugs. Solid understanding of the necessary ICH and USP regulations and experience supporting regulatory submissions at various development stages is critical. We expect this role will evolve in scope and complexity as the programs advance to later stages of development.
This is a full-time, South San Francisco-based position with the expectation of working on-site at least three days per week.
KEY RESPONSIBILITIES
- Lead and implement the overall analytical development plan for the portfolio assets that encompass in-process controls, product release, characterization, comparability, impurity and residual testing, stability and degradation, physicochemical and biochemical characterization methods. Candidate is expected to work with external CDMOs and CTLs to find the most efficient and scientifically sound plan and implement it for manufacturing at the CDMOs.
- Oversee development and phase appropriate qualification or validation of analytical methods for release, stability, comparability and in-process testing.
- Collaborate cross functionally with process development, QA/QC, Regulatory CMC to support IND filings, BLAs and other regulatory documents.
- Guide method transfer and troubleshooting at contract testing labs and CDMOs.
- Personally engage in data review and method optimization for complex physicochemical and bioassay methods
- Lead characterization studies to support structural elucidation, product profile variant assays (size, charge glycosylation) and in the future binding assays
- Develop phase appropriate control and release strategy, specifications to support GMP manufacturing of drug substance and drug product
- Provide necessary technical oversight of the development and QC activities at the CDMO/CTLs
- Ensure compliance with ICH, cGMP and regulatory requirements
- Develop comparability strategy and plans in support of process and product life cycle changes and also in support of clinical development plans.
- Plan and prioritize resources across programs in a lean, dynamic environment.
- Help establish Marea’s long-term analytical infrastructure, balancing external outsourcing with selective in-house build-out.
QUALIFICATIONS
- PhD in Analytical Chemistry, Biochemistry or related discipline with 12+ years of relevant experience (Senior Director level) or 15+ years of experience (Executive Director level) in biologics drug development focused on analytical development. The level of the role is flexible between Senior and Executive Director based on years and totality of experience.
- Expertise in key analytical methods for development of monoclonal antibody drugs, including: HPLC/UPLC (SEC, IEC, RP), CE-SDS, IEF, mass spectrometry (intact and peptide mapping), ELISA, cell-based assays, binding kinetics
- Experience with cell-based assays is desirable
- Proven experience in authoring content for regulatory submissions and preferably interacting with health authorities
- Experience working with CDMOs and contract testing labs
- Hands-on experience troubleshooting and optimizing complex analytical methods; ability to dive deep into technical data when needed.
- Track record of supporting programs through IND, late-stage development, and BLA, including direct regulatory interactions.
- Strong leadership skills specifically working cross-functionally with internal team and with external partners
- Exceptional ability to flex between strategic planning and hands-on execution in a lean, start-up environment.
PAY RANGE
The salary range for this role is $250,000 - $295,000. Compensation and title will be competitive and commensurate with the candidate's experience, qualifications, and the responsibilities of the position.
WORKING CONDITION
- The role may need to occasionally work in laboratory environment.
- Travel to CDMOs/CTLs may be needed up to 10% of the time (variable, with some peak windows)
#LI-Hybrid
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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