Associate Principal Scientist, Biologics Analytical R&D

Job Overview

Associate Principal Scientist – Biologics Analytical Research & Development (BAR&D) – Rahway, New Jersey

A laboratory‑based scientific role focused on solving complex analytical challenges to enable development of biologics drug products. The position requires strong collaboration in a fast‑paced, multidisciplinary team environment.

• 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/techniques to industry standards.
• Technical leadership of design of experiments and data interpretation.
• Design, execute, and direct release, stability and characterization methods for clinical trial material in support of product/process development per ICH Q2 (R2).
• Co‑design, draft, execute/direct work related to method bridging, comparability, setting of specifications, and complete reporting.
• Author and review SOPs, technical reports, publications, and regulatory filings (e.g., IND, BLA).
• Lead small groups of technical personnel and analytical projects; provide matrix management and peer‑to‑peer coaching.

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

• Hands‑on experience in separation sciences with chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis (CE‑SDS, iCIEF) for biologics.
• Residue impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
• Method bridging, comparability, specifications setting, and complete reporting.
• Design and execution of release/stability and characterization methods according to ICH Q2 (R2) guidance.
• Excellent oral and written communication skills; ability to work independently and cross‑functionally.
• Experience with matrix management and peer‑to‑peer coaching.

• Design of Experiments principles and statistical data analysis using JMP, Mini Tab, FusionAE, etc.
• Broad knowledge of biologics assays, charge & size variants, glycans, purity/impurity.
• Understanding of protein degradation mechanisms and link between analytical/orthogonal methodologies.
• Experience with qualification, validation, and transfer of assays to GLP or regulated laboratories per ICH Q2 and USP 1033.
• Representation of analytical functional area on project teams.
• Experience with biologic modalities such as mAb, antibody‑drug conjugates, fusion proteins.
• Experience in data analytics.

• Analytical R&D, Biochemistry, Biological Assay Development, Cell‑Based Assays.
• Chromatographic Techniques, ELISA, HPLC, HRMS, Immunoassays, Ion Exchange, LC, LC‑MS, Mass Spectrometry.
• Pharmaceutical Sciences, Real‑Time PCR, Separation Sciences, Teamwork.

We are 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.

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