Sr Scientist, AMD Lead

San Diego, CA

Scientific – Analytical Development /

Full Time /

On-site

With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.

Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.

We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.

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 biologics
Experience supporting analytical control strategies for large‑molecule drug substance and drug product.
Exposure to phase‑appropriate 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 cross‑functional and matrixed teams.
Proficiency with Microsoft Office applications and electronic documentation systems such as SharePoint.

$110,000 - $155,000 a year

FLSA: Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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