Associate Principal Scientist, Biologics Analytical R&D

Job Description

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

This laboratory‑based scientific role involves solving complex analytical challenges and supporting the development of biologics drug products. The successful candidate will work collaboratively in a fast‑paced, multidisciplinary team to develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal and other complex therapeutic proteins. Key responsibilities include the development of new assay platforms, benchmarking current approaches/techniques against industry standards, and providing technical leadership in design of experiments and data interpretation.

• Develop, qualify, and transfer analytical methods for monoclonal and complex therapeutic proteins.
• Design and execute new assay platforms and benchmark against industry standards.
• Lead design of experiments and data interpretation for method development.
• Provide technical guidance across method bridging, comparability studies, and specification setting.
• Develop, qualify, and support release/stability and characterization methods for clinical trial material in accordance with ICH Q2 (R2) guidance.
• Prepare SOPs, technical reports, publications, and regulatory filings such as IND and BLA submissions.
• Coach and mentor technical personnel and manage matrix projects.

• Education:
  
  B.S. in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field with 10+ years of experience; or M.S. with 7+ years; or Ph.D. with 3+ years of relevant experience.
• Hands‑on experience in chromatography (SEC, RP, IEX, HILIC) or capillary electrophoresis (CE‑SDS, iCIEF) for biologics.
• Experience in residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
• Ability to co‑design, draft, and execute methods from protocol to final report, including method bridging and comparability studies.
• Strong oral and written communication skills; ability to work independently and cross‑functionally.
• Experience authoring and reviewing SOPs, technical reports, publications, and regulatory filings.
• Experience with matrix management and peer‑to‑peer coaching.

• Design of Experiment 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 linking analytical/orthogonal methodologies.
• Experience in assay qualification, validation, and transfer to GLP or regulated laboratories (ICH Q2, USP).
• Representation of the analytical functional area on project teams.
• Experience with various biologic modalities (mAb, ADC, fusion protein).
• Data analytics experience.

Salary range: $142,400 – $224,100. Eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, retirement (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 legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the EEOC resources.

Requisition : R404891

Job Posting End Date: 07/14/2026