Scientist III, Gene Therapy Analytics

Location
Durham, NC, United States
Posted
Sep 19, 2020
Ref
1372603
Hotbed
Bio NC
Required Education
Doctorate/PHD/MD
Position Type
Full time
The Scientist III will develop, adapt, implement and execute physicochemical assays and immunoassays in support of a broad portfolio of cell and gene therapies across the development lifecycle. This role will initially be an individual contributor position focused on supporting Precisions expanding Gene Therapy/AAV portfolio, as well as CAR T impurity testing. The position may grow into leading a small team of 3-6 direct reports, if appropriate. This is a unique opportunity to contribute to the overall analytical sciences program at a rapidly growing biotechnology company focused on the discovery and clinical development of highly novel genome-edited therapeutics for immuno-oncology and genetic disease, that currently has 220 employees and a highly people- and patient-centric, science-driven culture.

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.
  • Develop, implement and manage the lifecycle of assays utilizing physicochemical assays and immunoassays to detect, characterize and quantify drug substances and drug products and their product and process impurities
  • Support pre-clinical, IND-enabling and BLA-enabling activities
  • Develop methods which are pre-validated and in compliance with ICH, FDA, EMA and other relevant guidelines
  • Analytical method development and support using HPLC, UHPLC or UPLC with detection by MALS, UV, FLR, CAD, ELSD detectors
    • Size exclusion LC separation experience
    • IEX LC separation experience
  • Develop, implement, and maintain phase-appropriate physicochemical assays and immunoassays with responsibility for analytical methods and standard operating procedures (SOPs) and development reports

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Education/Experience

Required:
  • PhD in Immunology, Physical Chemistry or related field, with a minimum of 6 years related industry experience or an MS degree with a minimum of 8 years related industry experience developing analytical testing for commercial or late stage clinical or commercial products
  • Experience with required analytical methods as described, including within academic and industry settings
  • Familiarity with FDA regulations, ICH guidelines, especially those pertaining to the analytical assays for testing
  • Familiarity with HPLC systems; further knowledge of these softwares for processing data from other detectors or pursuance of data integrity goals is a significant plus

Preferred:
  • Experience with some combination of the following:
    • Nucleotide sequence confirmation (identity testing) of DNA or RNA
    • Plate-based immunoassays
    • Gene therapy/viral vectors (esp. AAV)
    • DP/DS impurity assessments
    • Mammalian cell culture
    • Cell-based assays
  • Familiarity with plate reader software, especially SoftMax
  • Familiarity with statistical processing software is a plus
  • Experience with particle and biological molecule sizing technologies and assays, including DLS, Nanosight or AUC
  • Prior experience in the development and pre-validation of analytical assays, including the preparation of analytical methods and standard operating procedures (SOPs) and supporting assay transfers to QA and/or CRO organizations as appropriate
  • Strong communication skills to explain assay development methodologies, challenges, and milestones to a broad variety of stakeholders

Travel Requirements
  • This position requires limited travel (10-15%)

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.