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 is tasked with solving complex analytical challenges to enable the development of Biologics drug products. The successful candidate will be able to work well in a collaborative, fast‑paced, multidisciplinary team environment. Responsibilities include the development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins;

development of new assay platforms; benchmarking current approaches/techniques to industry standards; and providing technical leadership of design of experiments and data interpretation. The candidate should be highly organized, possess excellent oral/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, and evidence of strong cross‑functional collaboration in an academic or industrial setting, are preferred.

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

• Hands‑on experience in separation sciences with chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (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, specification setting, from protocol to final report.
• Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material, supporting 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 relevant 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 on 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 (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

The salary range for this role is $ – $. This range represents the lowest to highest salary we believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare, and other insurance benefits for employees and families; retirement benefits including…