Principal Scientist, Biologics Analytical R&D

Principal Scientist – Biologics Analytical Research & Development

Location:

Rahway, New Jersey – Research Laboratory

The Biologics Analytical Research & Development department of our Company’s Research Laboratories Division is seeking a Principal Scientist to work closely with the group Director to define analytical strategy and lead a team of scientists.

• Define analytical strategy for biologics active pharmaceutical ingredients (APIs).
• Lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and laboratory informatics.
• Mentor team members and foster cross‑functional collaboration.
• Drive project delivery and ensure alignment with development goals.
• Contribute to the design, execution, and qualification of release, characterization, and stability assays for clinical trial material.
• Produce internal technical reports and contribute to regulatory filings (IND, BLA).

Education and Experience

• Ph.D. in analytical chemistry, biochemistry, or related field with a minimum of 8 years of experience in the pharmaceutical industry.
• M.S. in analytical chemistry, biochemistry, or related field with a minimum of 10 years of experience in the pharmaceutical industry.
• B.S. in analytical chemistry, biochemistry, or related field with a minimum of 14 years of experience in the pharmaceutical industry.

Required Experience and Skills

• Extensive experience in analysis of biologics (SEC, IEX, CE).
• Experience in 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 matrix‑management skills.
• Ability to innovate and solve problems creatively.
• Knowledge of Critical Quality Attributes, QbD/DOE principles, and statistical data analysis.
• Design and qualification of release, characterization, and stability assays for clinical trial material.
• Excellent oral and written communication; ability to work independently and cross‑functionally.
• Experience authoring regulatory filings and scientific publications.
• Deliver complex objectives under aggressive timelines.

Preferred Experience and Skills

• Understanding of protein degradation mechanisms and linkage between analytical methodologies.
• Experience with qualification, validation, and transfer of assays to a GxP or regulated laboratory environment per ICH Q2 and USP.
• Experience in glycan analysis and biologic modalities (mAb, ADC, fusion protein).
• Experience in antibody drug conjugate method development.
• Established scientific reputation and external network.
• High‑throughput experimentation and data‑rich experimentation.

Salary Range: $156,000 – $247,000

Annual bonus and long‑term incentive potential. Comprehensive benefits package: medical, dental, vision, retirement (401(k)), paid holidays, vacation, and other insurance benefits.

We are an Equal Employment Opportunity Employer. We provide equal opportunities for 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

U.S. Hybrid Work Model:
Employees in U.S. office‑based positions will work a hybrid schedule of three on‑site days per week, Monday‑Thursday, with Friday remote (unless required on‑site). This model does not apply to field‑based, facility‑based, or research‑based positions.

US and Puerto Rico Residents Only:
Applicants must be able to work in the U.S. and may need more information if accommodations are required.