Associate Principal Scientist, Biologics Analytical R&D

Job Description:

The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This laboratory‑based scientific role focuses on solving complex analytical challenges to support biopharmaceutical product development. The successful candidate must thrive in a collaborative, fast‑paced multidisciplinary team environment and will be responsible for development, qualification, implementation, troubleshooting, and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins.

Development, qualification, implementation, troubleshooting, and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins.

Development of new assay platforms and benchmarking current approaches and techniques to industry standards.

Providing technical leadership in design of experiments and data interpretation.

Applicants must be highly organized, possess excellent oral and written communication skills, display scientific leadership, and have a desire to conduct research and publish.

Experience leading small groups of technical personnel and analytical projects is preferred, as is evidence of strong cross‑functional collaboration in an academic or industrial setting.

• Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field.
• B.S. with 10+ years of experience.
• M.S. with 7+ years of experience.
• Ph.D. with 3+ years of relevant experience.

• Hands‑on experience in separation sciences with chromatography (e.g., SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE) analysis (e.g., CE‑SDS, iCIEF) for biologics.
• Experience with residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
• Ability to co‑design, draft, execute/direct work related to method bridging, comparability, and setting of specifications from protocol to final report.
• Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
• Excellent oral and written communication skills; ability to work independently and cross‑functionally.
• Authoring and reviewing of SOPs, technical reports, publications, and appropriate sections of regulatory filings (e.g., IND, BLA).
• Experience with matrix management and peer‑to‑peer coaching.

• Design of Experiment principles including statistical data analysis using JMP, Mini Tab, FusionAE, etc.
• Broad knowledge of the panel of biologics assays: charge & size variants, glycans, purity/impurity.
• Understanding of protein degradation mechanisms and the link between analytical/orthogonal methodologies for analysis.
• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP 1033.
• Experience representing the analytical functional area on project teams.
• Experience in analysis of various biologic modalities (e.g., mAb, antibody‑drug conjugate, fusion protein).
• Experience in data analytics.

• Analytical Research and Development (R&D)
• Biochemistry
• Biological Assay Development
• Cell‑Based Assays
• Chromatographic Techniques
• Enzyme Linked Immunosorbent Assay (ELISA)
• High‑Performance Liquid Chromatography (HPLC)
• High Resolution Mass Spectrometry (HRMS)
• Immunoassays
• Ion Exchange
• Liquid Chromatography (LC)
• Liquid Chromatography‑Mass Spectrometry (LC‑MS)
• Mass Spectrometry Analysis
• Pharmaceutical Sciences
• Real Time Polymerase Chain Reaction (qPCR)
• Separation Sciences
• Teamwork

Salary range: $ – $ (lowest to highest).

Eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, healthcare and other insurance benefits for employee and family; retirement benefits including 401(k); paid holidays, vacation, and compassionate and sick days.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

Job Posting End Date: 07/14/2026