Job Description

Summary

The Scientist I, CMC-Analytical Development– Cell Biology, will perform as technical subject matter expert in the Cell Therapy bioassay/Immunoassay/Flow Cytometry group of Precision BioSciences. Within the CMC-Analytical Development department, this individual will coordinate development of highly novel methods, method optimization, and method execution and data analysis for the functional characterization of genome-edited cell therapy and gene therapy products. The incumbent will support efforts to develop analytical methods in support of cell therapy and gene therapy product in-process control and release. As a subject matter expert for cellular immunology and molecular biology, the Scientist I will interface with multiple stakeholders including Clinical Affairs, Technical Operations, Quality, and Regulatory to advance a pipeline of allogeneic CAR-T cell products 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:

Develop, characterize, optimize and document analytical methods for the testing of genome-edited cell therapy and gene therapy products. Participate in transfer of assays to QC group, as appropriate
Multi-color Flow Cytometry
Immunoassay
Bioassay
Molecular assays (qPCR and dPCR)
Lead and coordinate multiple programs simultaneously with limited oversight from management
Mentor and train laboratory staff in the development and execution of cellular and molecular assays
Author, review and approve technical documents
Stay abreast of advances in the field of CAR-T cell therapy and gene 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.

Education/Experience

Required:

Master’s degree (M.S/M.A.) in the biological sciences with 5+ years of related biopharma industrial experience and/or training, or equivalent combination of education and experience
Experience with molecular biology assays (qPCR and/or dPCR)
Experience in multi-parametric flow cytometry.
Experience with cellular assay development, including multiplex cytokine analysis and immunological functional assays
Experience with mammalian cell culture

Preferred:

Background in immunology
Ability to conduct research projects independently and analyze results
Strong communication skills, including written and verbal reporting to supervisor, team, multiple stakeholders across the company, and at conferences.

Travel Requirements