Sr Scientist, AMD Lead

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
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We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.

The Senior Scientist, AMD Lead is responsible for providing analytical development leadership across multiple client programs. This role serves as the primary point of contact for AMD activities within assigned projects and coordinates analytical strategy, experimental design, method development, and testing execution in support of activities including, but not limited to process development, in‑process monitoring, and drug substance and drug product release. This position is primarily project- and strategy-focused, with a smaller lab‑based component aiding to onboard MS-based methods for the analysis of biologics and complex biologics and is suited for a mid‑ to senior‑career scientist with broad experience in biologics analytical development. The AMD Lead collaborates closely with Quality Control (QC), Quality Assurance (QA), Process Development, Project Management, and external clients supporting clinical and commercial-stage therapeutics.

Responsibilities

• 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, in‑process 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 spectrometry‑based methods.

• Maintain a limited hands‑on laboratory role, primarily focused on onboarding, development, optimization, or troubleshooting MS‑based 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 phase‑appropriate 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 cross‑functional interfaces.

Qualifications

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

  • Hands-on experience in mass spectrometry‑based methods for biologics and complex b