Sr Scientist, AMD Lead at Abzena Inc. – San Diego, California

Serve as the primary Analytical Method Development (AMD) Lead and point of contact for assigned client programs, providing scientific leadership and strategic direction across analytical activities.

Lead and coordinate analytical strategy, experimental design, and execution supporting process development, inprocess monitoring, and drug substance and drug product release.

Oversee method feasibility, development, optimization, qualification, and validation, ensuring alignment with program phase, project timelines, and regulatory expectations.

Provide subject matter expertise across a broad range of analytical techniques for biologics and complex biologics, including chromatographic, electrophoretic, immunochemical, and mass spectrometrybased methods.

Maintain a limited handson laboratory role, primarily focused on onboarding, development, optimization, or troubleshooting MSbased analytical methods, and enabling effective technology transfer to analytical teams.

Collaborate with AMD functional leads to define analytical testing strategies, prioritize activities, and ensure timely execution of project deliverables.

Partner closely with Process Development, Quality Control (QC), Quality Assurance (QA), and Project Management to ensure alignment of analytical plans and integrated project execution.

Present analytical data, approaches, risks, and recommendations to internal stakeholders and external clients, translating complex results into clear scientific conclusions.

Support development of analytical control strategies, specifications, and phaseappropriate regulatory documentation for clinical and commercial programs.

Review, interpret, and approve analytical data; author and review SOPs, protocols, validation reports, study reports, and certificates of testing as required.

Identify opportunities to improve analytical processes, workflows, and procedures within AMD and across crossfunctional interfaces.

Minimum B.S. with 10–14 years, M.S. with 7–12 years, or Ph.D. with 5–10 years of relevant industry experience in analytical chemistry, biochemistry, biophysics, or a related scientific discipline.

Demonstrated experience in analytical method development, optimization, qualification, and validation for biologics.

Strong technical background in analytical techniques including, but not limited to:

• HPLC and LCMS separations, Capillary electrophoresis and isoelectric focusing, ELISA and other immunoassays, Western blotting, Protein titer methods (HPLC, ELISA, SPR)

Hands-on experience in mass spectrometrybased methods for biologics and complex biologics

Experience supporting analytical control strategies for largemolecule drug substance and drug product.

Exposure to phaseappropriate regulatory expectations and filing strategies in the U.S. and internationally.

Preferred experience operating in cGMP environments, with familiarity with ICH guidelines and USP/EP compendial methods.

Strong ability to manage multiple projects simultaneously and work effectively under pressure.

Excellent oral and written communication skills, with the ability to present complex scientific data clearly to diverse audiences, including clients.

Ability to work both independently and collaboratively within crossfunctional and matrixed teams.

Proficiency with Microsoft Office applications and electronic documentation systems such as SharePoint.