Associate Principal Scientist – Bioassay, Cell Sciences, AR&D

Overview

Large Molecule Analytical Senior Scientist within the Company's Research Laboratories seeks a highly motivated senior scientist with extensive experience developing potency assays for biologics to join the Biologics Potency team within Cell-Based Sciences in Rahway, New Jersey.

• Define potency strategy and develop and optimize immune binding assays and cell-based assays for biologics development.
• Conduct non-GMP qualification and robustness studies and perform non-GMP sample testing.
• Support potency method transfers and validation at GxP testing laboratories.
• Represent potency on cross-functional product development teams.
• Contribute to the authoring and review of regulatory submissions and technical reports.
• Provide scientific mentoring to junior scientists.
• Communicate effectively with stakeholders in partner organizations, management, and governance teams.
• Maintain accurate and detailed laboratory records.

• Ph.D. in cell biology, immunology, biochemistry, molecular biology, or a related field with a minimum of 4 years of industry experience in the biopharmaceutical industry; or
• M.S. in cell biology, immunology, or a related field with a minimum of 8 years of relevant industry experience; or
• B.S. in cell biology, immunology, or a related field with a minimum of 12 years of relevant industry experience.
• Expertise in cell biology and immunology, with application to solving complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities.
• Hands‑on experience developing immune binding assays and cell-based functional assays, with proficiency in stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, and reporter gene assays.
• Working knowledge of Quality by Design (QbD) and Design of Experiments (DOE) principles, and strong statistical skills for data interpretation in the context of broader process and product development.
• Proficiency in common bioassay software and data analysis packages such as Soft Max Pro, JMP, PLA software, Graph Pad Prism, and Microsoft Office tools.
• Experience mentoring peers and junior scientists.
• Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with health authorities.
• Track record of scientific engagement, including scientific publications, industry white paper contributions, and presentations at scientific meetings.
• Demonstrated ability to deliver complex objectives and work effectively in a collaborative, fast‑paced, and dynamic cross‑functional team environment.
• Excellent verbal and written communication skills.

• Analytical Method Development
• Antibody Drug Conjugates (ADC)
• Assay Development
• Biological Assay Development
• Biopharmaceutical Industry
• Biopharmaceuticals
• Biopharmaceutics
• Cell-Based Assays
• Cell Physiology
• Chromatographic Techniques
• Cytotoxicity
• High Resolution Mass Spectrometry (HRMS)
• Immunoassays
• Immunology
• Liquid Chromatography-Mass Spectrometry (LC-MS)
• Mass Spectrometry Analysis
• Molecular Biology

• Cell Biology

• Salary range: $ – $.
• Potential eligibility for annual bonus and long‑term incentive if applicable.
• Comprehensive benefits package including medical, dental, vision, healthcare and other insurance benefits (for employee and family), retirement benefits (including 401(k)), paid holidays, vacation, compassionate and sick days.

We are committed to inclusion and provide equal opportunities to all employees and applicants for employment. We 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.