Senior Director, Analytical Development en 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

The Senior 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 personally reviewing data packages or 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 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. Solid understanding of the necessary ICH and USP regulations and experience supporting regulatory submissions at various development stages is critical We expect this candidate to be hands on and be adaptable to the evolving needs in a start-up environment.

Requirements

·  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

·  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 in biologics drug development focused on analytical development

·  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.