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Scientist, CMC BioAssay Development

Company: Precision BioSciences
Location: Durham
Posted on: February 16, 2020

Job Description:

The Scientist, CMC BioAssay Development will oversee and coordinate within the CMC Analytics group novel method development, method optimization and execution for the potency and functional characterization (as appropriate) of Cell and Gene Therapy DSI/DS and DP. The Scientist will lead efforts to develop analytical methods in support of CGT product in-process control and release. The Scientist will also oversee and drive development and incorporation of automation, as appropriate. As a subject matter expert for cell-based and immunochemistry-based analyses, the Scientist will interface with multiple stakeholders including Clinical Operations, Technical Operations, Quality and Regulatory to advance a pipeline of allogeneic CAR-T and Gene Therapy products a from IND filing through to commercial launch. Essential Duties and Responsibilities Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document. Primary responsibilities will include: Design, develop, characterize and document analytical and/or potency methods for cell therapy and gene therapy products Lead and coordinates multiple programs simultaneously with very limited oversight from management Mentor and train laboratory staff in the development and execution of cellular and immunochemical assays Author, review and approve technical documents Work with a cross-functional team to advance genome-edited cell therapy programs. Stay abreast of advances in the field of AAV and CAR-T cell therapy, including reviews of scientific literature and attendance at conferences Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required: PhD in Biological Sciences and at least 8 years of biopharmaceutical experience, or equivalent combination of education and experience Ability to conduct and oversee projects independently and analyze/defend results Strong experience in cell-based assay and immunoassay development, including multiplex cytokine analysis, cellular metabolomics and immunological functional assays Strong experience in application of automation to cell-based and immunochemistry-based analyses Strong communication skills, including written and verbal reporting to supervisor, team, multiple stakeholders across the company, and at conferences Preferred: Experience with mammalian cell culture Travel Requirements This position requires little travel Location This is an office-based position located at the main headquarters in downtown Durham, NC. Precision BioSciences is dedicated to improving life through its proprietary genome editing platform, ARCUS. Precision BioSciences leverages ARCUS in the development of its product candidates which are designed to treat human diseases and create healthy and sustainable food and agriculture solutions. Precision BioSciences is actively developing product candidates in three innovative areas: allogeneic CAR T immunotherapy, in vivo gene correction, and food. Precision BioSciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Precision BioSciences complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Keywords: Precision BioSciences, Durham , Scientist, CMC BioAssay Development, Other , Durham, North Carolina

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