Principal Scientist, Molecule Analytical

Job Overview

The Biologics Analytical Research & Development department of our company's Research Laboratories Division is seeking a Principal Scientist to work at its Rahway, New Jersey research facility. This senior scientific position works closely with the group director to define analytical strategy and lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics, enabling development of biologics active pharmaceutical ingredients (APIs).

• Define analytical strategy in collaboration with the group director.
• Lead and mentor a team of scientists, managing technical personnel.
• Solve complex analytical problems involving biologics, chromatography, and bioanalytical methods.
• Develop and execute analytical control strategies, including assay development and qualification.
• Prepare internal technical reports and regulatory documentation (IND, BLA).
• Ensure timely delivery of projects in a rapidly changing environment.

• Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, or equivalent.
• M.S. with a minimum of 10 years of experience, or B.S. with a minimum of 14 years of experience.
• Extensive experience in analysis of biologics (SEC, IEX, CE).
• Experience with process‑ and impurity‑related residual assay development using molecular biology and immunoassay techniques.
• Strong background in analytical control strategy development and execution.
• Proven mentoring and coaching ability within a matrix environment.
• Knowledge of QbD/DOE principles and data analysis for setting specifications.
• Ability to design, execute and/or direct development and qualification of release, characterization and stability assays for clinical trial material and product process development.

• Understanding of protein degradation mechanisms and their link to analytical methodologies.
• Experience with qualification, validation and transfer of assays in a GxP or regulated laboratory environment (ICH Q2, USP).
• Experience with complex glycan analysis and correlation to mechanisms of action.
• Experience in analysis of various biologic modalities (mAb, ADC, fusion protein).
• Knowledge in ADC method development and a strong external network of vendors.
• High‑throughput experimentation and data‑rich analysis experience.
• Established scientific reputation supported by publications and external presentations.

• Salary range: $ – $.
• A competitive bonus and long‑term incentive structure may apply.
• Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days, and other insurance benefits.

• Location:
  
  Rahway, New Jersey.
• Visa Sponsorship:
  Yes.
• Travel Requirements: 10%.
• Relocation:
  Domestic.
• Job Posting End Date: 07/31/2026.

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. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about your rights, please visit the EEOC resources listed by the U.S. Equal Opportunity Employment laws.