Executive Director, Analytical Development and Drug Product 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 Executive Director of Analytical Development and Drug Product Development is a unique technical leadership opportunity that combines a broad scope of responsibilities: analytical development, method transfer and validation, comparability study design, formulation and drug product development to support Marea’s pipeline. Given the early stages of forming the Technical Operations organization at Marea in a start-up environment, this role has both strategic technical leadership as well as hands-on operational execution components.  This role is expected to set the vision for technical strategy for formulation, drug product and analytical development and at the same time a hands-on role providing technical oversight to external drug product CDMO/CTLs while being directly engaged in the detailed design, execution, and troubleshooting of methods and drug product processes.  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, initially reporting to the CTO.  The successful candidate will have strong technical background in developing biologics through various stages of development all the way to BLA submission. The candidate will work closely with other members of the technical operations team including process development, manufacturing, quality, CMC regulatory as well as cross-functionally with research and clinical team to support the program goals.  On the analytical part of the role, the 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. On the drug product side, the candidate needs to have experience in formulation and drug product process development as well tech transfer to CDMOs across both vial and pre-filled syringe configurations.  Good understanding of the necessary ICH and USP regulations and experience supporting regulatory submissions at various development stages is desired.   

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.  

·  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 author/review 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 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 in the long run.

·  Lead formulation and drug product development activities for monoclonal antibodies in the portfolio that spans early and late-stage CMC development

·  Design and execute pre-formulation and formulation studies (typically at CDMO) 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.

·  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

QUALIFICATIONS

·  PhD in Analytical Chemistry, Biochemistry, Pharmaceutical science, Chemical Engineering or related discipline with 15+ years of relevant experience in biologics development focused on analytical development, formulation science and drug product manufacturing

·  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

·  Hands-on experience troubleshooting and optimizing complex analytical methods; ability to dive deep into technical data when needed.

·  Experience supporting or leading complex analytical comparability exercises

·  Experience with cell-based assays is a plus

·  Proven experience in authoring content for regulatory submissions and preferably interacting with health authorities

·  Experience working with CDMOs and contract testing labs

·  Solid understanding of protein formulation principles, stability challenges, and container/closure compatibility

·  Experience with drug product process development (both vials and PFS), tech transfer in a CDMO environment

·  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.