Associate Principal Scientist, Biologics Analytical R&D

Associate Principal Scientist – Biologics Analytical Research & Development (BAR&D)

Location:

Rahway, New Jersey. The Associate Principal Scientist is a laboratory‑based scientific role tasked with solving complex analytical challenges to enable the development of biologics drug products. The successful candidate will function well in a collaborative, fast‑paced, multidisciplinary team environment.

• Develop, qualify, implement, troubleshoot, and transfer analytical methods for monoclonal proteins or other complex therapeutic proteins.
• Develop new assay platforms and benchmark current approaches/techniques against industry standards.
• Provide technical leadership in the design of experiments and data interpretation.

• Education
  :
  Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field, B.S. with 10+ years of experience, M.S. with 7+ years, or Ph.D. with 3+ years of relevant experience.
• Required Experience and Skills
  :
  Hands‑on experience in separation sciences with chromatography (SEC, RP, IEX, HILIC) and/or capillary electrophoresis analysis (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, specifications, etc.; design and direct development of release/stability and characterization methods per ICH Q2 (R2) guidance;
  
  excellent oral and written communication; authoring and reviewing SOPs, reports, publications, regulatory filings (IND, BLA); experience with matrix management and peer coaching.
• Preferred Experience and Skills
  :
  Design of Experiments principles including 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; qualification, validation, and transfer of assays to GLP or regulated labs under ICH Q2 and USP; representing analytical functional area on project teams; analysis of various biologic modalities (mAb, ADC, fusion protein);
  
  data analytics.

• Salary range: $ – $.
• Eligible for annual bonus and long‑term incentive, if applicable.
• Comprehensive benefits package including medical, dental, vision, retirement (401(k)), paid holidays, vacation, 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.

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Job posting end date: 07/14/2026. Requisition : R404891.