Director, Bioanalytical Development

Working with the Cell Therapy Development Team, provide strategic and technical T cell biology and molecular immunology leadership for the functional characterization of allogeneic CAR T cell drug products and drug, as well as cellular starting materials and viral vector drug substance intermediates, to inform product understanding and process/ product relationships, including analysis and management of large data-sets. Lead bioanalytics development efforts for CARs and TCRs by providing assay development, verification, validation, and standardization. Collaborate across all functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. Play key role in product life cycle, including development/characterization, commercialization, licensure, and evolution of cell therapy products. Development, characterization, optimization and validation of bioanalytical methods for product quality testing, release, and technology transfer to a qualified CMO for scale up of a cGMP-compliant manufacturing process. Design new experiments to identify and test new analytical methods as part of process improvement for existing product as well as development of new products for cell therapy. Develop, optimize, qualify and validate assays which includes cell-based CTL, multi-color FACS, ELISPOT, proliferation assay and multiple (multiplex) cytokine assay to define product identity, purity, uniformity, potency, and stability as part of product batch release testing. Author and review standard operating procedures, batch records, process flow diagrams within the Quality Systems environment of Precision Biosciences. Contribute to preparation of regulatory documents (INDs, Briefing Documents, BLAs and stability protocols). Perform testing for selection and qualification of raw materials and intermediates that are used in various processes involved in production of cell therapy products. Prepare reports on equipment qualification protocols, assay flow diagrams, and other documentation. Innovate new test methodologies and stay current with cutting-edge techniques in cell therapy bioanalytics. Read, analyze, and interpret common scientific journals to define problems, collect and analyze data, establish facts, and draw valid conclusions Directly supervises a team of 4 scientists.

Requirements:

PhD (or foreign degree equivalent) in Immunology, Cell or Molecular Biology, Biological Sciences or closely related discipline, plus three (3) years of experience in the job offered or similar biopharma process development positions.

In the alternate, will accept a Masters (or foreign degree equivalent) in Immunology, Cell or Molecular Biology, Biological Sciences or closely related discipline, plus six (6) years of experience in the job offered or similar biopharma process development positions.

Special skills which apply to all applicants:

Must have two (02) years of experience in:

• Cell based analytical assay development and validation for cell therapy manufacturing processes intended to support GMP manufacturing.
• SOP writing and review experience.
• Cell culture or aseptic processing.
• cGMP and GLP requirements and preparation of applicable Regulatory documents.
• Multiparameter flow cytometric analysis including phosphoproteins, RNA Flow, calcium flux, and DNA content.
• Multiplexed measurements of soluble factors (Luminex or a similar platform).
• In vitro assays of cell function (such as CTL or proliferation assays).
• In vitro fluorescence/luminescence assays.
• Magnetic separation.
• High density cell culture.
• Residuals testing (beads, viral particles, FBS or other ancillary materials).
• Automated cell counting and viability methodologies.
• In-process drug substance and drug product release testing methodologies.
• T cell biology, primary T cell culture in serum free media supplemented with cytokines to foster expansion of specific cellular phenotypes.
• Characterization and development of cell and immune based testing methods.

Travel required domestically/internationally (10%) during transfer phase of projects.

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.