Senior Scientist - Biologics Potency, Cell Based Sciences, AR&D

Job Description

The Analytical Research & Development of our company Research Laboratories is seeking a highly motivated senior scientist to join the Biologics Potency team within the Cell-Based Sciences in Rahway, New Jersey,  The qualified candidate will be responsible of potency bioassay development, method design and optimization, non-GMP qualification and robustness, and method transfer to GxP testing laboratories, to assess the biological activity of various biologics modalities such as therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or complex modality-based products.

 

Key Responsibility:

• Develop and optimize immune binding assays and cell-based assays for biologics development.

• Conduct non-GMP qualification and robustness study to support assay validation.

• Support method transfers to internal and external GxP laboratories.

• Collaborate with cross-functional teams to support biologics development.

• Maintain accurate and detailed laboratory records.

• Contribute to the preparation of regulatory submissions and technical reports.

 

Qualifications: 

Education

• Ph.D. in cell biology, immunology, biochemistry, molecular biology or a related field, OR

• M.S. in cell biology, immunology or a related field with a minimum of 5 years of relevant industry experience, OR

• B.S in cell biology, immunology or a related field with a minimum of 8 years of relevant industry experience.

Required Experience

• Hands-on experience with cell-based assays.

• Strong written and verbal communication skills.

• Collaborative.

• Excellent problem-solving skills and attention to detail.

• Ability to work independently and as part of a team.

Preferred Experience

• Hands-on experience with immunoassays

• Basic understanding of biological potency and assay development.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

AR&D

Required Skills:

Adaptability, Adaptability, Analytical Method Development, Antibody Drug Conjugates (ADC), Assay Development, Bioanalytical Analysis, Biochemical Assays, Biochemistry, Biological Sciences, Cell-Based Assays, Chromatographic Techniques, GMP Environments, Immunoassays, Immunochemistry, Immunology, Immunotherapy, Innovative Thinking, Microbiology, Molecular Biology, Monoclonal Antibodies, Nuclear Magnetic Resonance (NMR) Analysis, Polyclonal Antibody Production, Process Analytical Technology (PAT), Strategic Thinking, Technical Writing {+ 1 more}

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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 charact