Associate 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 drug 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 expertise, and creativity to solve complex project problems across the large molecule portfolio. They will be accountable to deliver and inspire scientific evaluation and implementation of innovative and disruptive technologies and approaches. Responsibilities include assay development, representing the group on product development teams and supporting defining the potency strategy for a portion of our large molecule portfolio, 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 4 years of industry experience in the Biopharmaceutical Industry.

• OR M.S. with a minimum of 8 years of experience in the Biopharmaceutical Industry.

• OR Bachelors with a minimum of 12 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 peers.

• Expertise in a variety of functional potency assay technologies, such as cell line engineering to build reporter gene assays, cytotoxicity assays. 

• Expertise in binding assays such as immunoassays.

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

• 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 is a plus.

• External scientific engagement that may include a combination of publications, industry white paper contributions, presentations at scientific meetings.

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

• Excellent verbal and written communications skills.

#AR&D

#EligibleforERP

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) …