Job Description
Large Molecule Analytical within our Company's Research Laboratories is seeking 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. The successful candidate will apply scientific expertise and creativity to solve complex project challenges across the large molecule portfolio, including therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or complex modality-based products. The candidate should cultivate and foster scientific and technological innovation, leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, champion new initiatives, and enhance functional capability and operational excellence.
Key Responsibilities:
- 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.
Qualifications:
- 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; 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; experience in new modality-based therapy development is preferred.
- Hands-on experience developing immune binding assays and cell-based functional assays, with proficiency in a variety of biological and immunological techniques, such as 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, as well as 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 SoftMax Pro, JMP, PLA software, GraphPad 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, which may include scientific publications, industry white paper contributions, and presentations at scientific meetings.
- Ability to excel in a team-based environment by partnering and influencing in a professional and positive manner.
- 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.
#AR&D
Required 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
Preferred Skills:
