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.

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 ‑ focused, with responsibility for overseeing and coordinating analytical activities rather than serving as the sole technical executor. The AMD Lead collaborates closely with Process Development (PD), Quality Control (QC), Quality Assurance (QA), Project Management, and external clients to ensure alignment across program phases. A limited hands ‑ on laboratory component may support onboarding, development, optimization, or troubleshooting of specific analytical methods as needed.

Responsibilities

• Serve as the primary Analytical Method Development (AMD) Lead and point of contact for assigned client programs, coordinating and supporting analytical activities across biologics and complex modalities, including monoclonal antibodies, bispecifics, fusion proteins, ADCs, and novel constructs; exposure to AAV, LNP, or mRNA platforms is preferred but not required.
• Lead and coordinate analytical strategy, experimental design, and execution supporting process development, in‑process monitoring, and drug substance and drug product release, ensuring analytical approaches are appropriate for program phase and client milestones.
• Oversee method feasibility, development, optimization, qualification, and validation for a range of assays, including but not limited to potency (cell‑based, binding, and functional assays), purity (SEC, icIEF, CE‑SDS) and impurity profiling (HCP, aggregates, residuals).
• 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, supporting technical decision‑making and troubleshooting. Provide limited hands‑on laboratory support as needed.
• Collaborate with AMD functional leads to determine analytical testing strategies, prioritize activities, and ensure timely execution of project deliverables in a CDMO environment with shifting priorities.
• Partner closely with Process Development (PD), Quality Control (QC), Quality Assurance (QA), and Project Management to support integrated program execution, including analytical method transfer to QC and alignment with qualification and validation expectations.
  
  

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)
• 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.