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

Job Description

The Analytical Research and Development, Cell Based Sciences team in Rahway, NJ is seeking a motivated scientist with technical expertise in Biologics Potency assays in Late Development. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or new modality-based products.  

The successful candidate is expected to provide scientific leadership, expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to inspire and sponsor scientific evaluation and implementation of innovative and disruptive technologies and approaches.  Responsibilities include representing the group on product development teams and defining the potency strategy for a portion of our large molecule portfolio, oversight of method development and testing, and scientific mentoring.  The candidate will be expected to effectively communicate with stakeholders in partner organization and to management and governance teams. 

Education Minimum Requirement:  

• Ph.D. in analytical chemistry, molecular biology, cell biology, or related field with a minimum of 8 years of industry experience in the Biopharmaceutical Industry.

• M.S. with a minimum of 10 years of experience in the Biopharmaceutical Industry.

• Bachelors with a minimum of 14 years of experience in the Biopharmaceutical Industry.

Required Experience and Skills: 

• Expertise in cell biology and immunology, with application to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities, preferably with experience in new modality-based therapy development. 

• Experience in mentoring and scientific leadership.

• Expertise in a variety of functional potency assay technologies, such as cell line engineering to build reporter gene assays, flow cytometry, natural killer (NK) cell assays for cytotoxicity assays. 

• Expertise in binding assays such as immunoassay.

• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development. 

• Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses (biologics license application submission) and interacting with Health Authorities.

• External scientific engagement that may include a combination of publications, industry white paper contributions, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.

• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.

• Excellent verbal and written communications skills.

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