Sr. Scientist, Analytical R&D

Job Description

Position Summary
We are seeking a highly motivated Senior Scientist to join the Biologics Potency team within Cell-Based Sciences (CBS), Analytical Research and Development (AR&D) at our company’s Research Laboratories in Rahway, New Jersey.

The successful candidate will be responsible for developing, pre-qualifying, assessing robustness, executing, and transferring immunoassays and cell-based potency assays to characterize the biological activity of a range of biologic modalities, including antibodies, multifunctional proteins, peptide therapeutics, antibody-drug conjugates, and novel biologics. A key component of this role is the design and implementation of digital and automation solutions to enhance assay performance, data quality, and operational efficiency.

Key Responsibilities

• Develop, optimize, and troubleshoot cell-based potency assays and immunoassays for biologics.

• Design and execute pre-qualification and robustness studies in support of assay validation and lifecycle management.

• Plan and execute cell-based potency and immunoassays, including stability studies and routine sample testing to support ongoing programs.

• Transfer assays to internal and external partners, including drafting protocols, training, and providing technical support as needed.

• Collaborate with cross-functional teams (e.g., Discovery, Process Development, Quality) to support biologics development from early to late stages.

• Maintain accurate, complete, and compliant laboratory records and documentation.

• Contribute to the preparation of technical reports, regulatory submissions, and responses to health authority questions.

• Use and design digital and automation solutions (e.g., electronic laboratory workflows, data analysis tools, automated liquid handling) to increase efficiency, robustness, and data integrity.

Educational Qualifications

• Ph.D. in Cell Biology, Biochemistry, Immunology, or a related field;
  OR M.S. in Cell Biology, Biochemistry, Immunology, or a related field with 5+ years of relevant industrial or academic experience;
  OR B.S. in Cell Biology, Biochemistry, Immunology, or a related field with 8+ years of relevant industrial or academic experience.

Required Qualifications

• Hands-on experience with cell-based assays and immunoassays (e.g., reporter gene assays, proliferation assays, ELISA, flow cytometry-based assays).

• Strong understanding of biological potency concepts, assay development, and assay performance characterization (e.g., accuracy, precision, linearity, specificity).

• Demonstrated problem-solving skills and attention to detail in experimental design, execution, and data analysis.

• Ability to work independently and effectively in cross-functional and matrixed team environments.

• Strong written and verbal communication skills, including the ability to document and present scientific data clearly.

Preferred Qualifications 

• Experience with potency assay validation and implementation in a GxP or regulated environment.

• Experience with automation and digital data workflows (e.g., automated liquid handlers, high-throughput platforms, scripting or data analysis tools such as R, Python, Spotfire, or similar).

• Experience supporting regulatory filings for biologics (e.g., IND, BLA, MAA) or interacting with health authorities.

#AR&D

Required Skills:

Accountability, Adaptability, Analytical Method Development, Assay Development, Bioanalytical Analysis, Biochemical Assays, Cell-Based Assays, Chromatographic Techniques, Communication, GMP Environments, Innovative Thinking, Nuclear Magnetic Resonance (NMR) Analysis, Process Analytical Technology (PAT), Strategic Thinking, Team Management, Technical Writing, Ultra Performance Liquid Chromatography (UPLC)

Preferred Skills:

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US and Puerto Rico Residents Only:

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