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Marea Therapeutics · 15 hours ago

Senior Director, Analytical Development

South San Francisco, CA

Full-time

Hybrid

Director/Executive

$231K/yr - $285K/yr

12+ years exp

Marea Therapeutics is a clinical-stage biotechnology company focused on developing first-in-class therapies for cardioendocrine diseases. The Senior Director of Analytical Development will lead the analytical development strategy, oversee method development, and collaborate with cross-functional teams to support regulatory submissions and ensure compliance with industry standards.

BiotechnologyGeneticsLife Science

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

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

Qualification

Analytical ChemistryMonoclonal Antibody DevelopmentRegulatory SubmissionsHPLC/UPLCMass SpectrometryCell-based AssaysTroubleshooting SkillsStrategic PlanningLeadership SkillsCross-functional Collaboration

Required

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

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