Quality Control Associate

Location
Durham, NC, United States
Posted
Aug 20, 2019
Ref
1116788
Discipline
Quality, Quality Control
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
Precision BioSciences is seeking a detail-oriented analytical chemist/biologist for a Quality Control Associate position. The QC Associate, within the Quality and Compliance Team, will report to and work closely with the Manager of Quality Control in establishing a state-of-the-art analytical laboratory to support clinical and commercial cellular and gene therapy products. The Quality Control Associate will perform analytical testing, test method validations, data review and support methodology transfers. This position requires working within the Quality Assurance team to ensure compliance with phase-appropriate FDA and other regulatory agency requirements.

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.
  • Perform and maintain HPLC-based assays for drug substance, drug product, and raw material testing per cGXP and compendial guidelines to support cell and gene therapy programs
  • Perform instrument qualifications and phase-appropriate test method validations
  • Perform maintenance and calibration of analytical instrumentation; troubleshoot equipment performance issues
  • Review test results of other QC personnel for accuracy and precision and maintain efficient workflow of all required testing documentation ensuring timely submission relative to product release dates
  • Author/review SOPs and technical documents, as required, in support of new methods
  • Assist the QC Team with maintaining proper overall operation of the department (physical inventories, logs, documentation, filing, etc.)
  • Train new staff in procedures, test methods and applicable regulations
  • Assist other Precision BioSciences teams with other projects and tasks, where applicable

Qualifications

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

Required:
  • MS with 5+ years experience or BA/BS with 10+ years experience in Chemistry, Biochemistry or related field preferred
  • Experience with HPLC testing of products in a cGXP environment
  • Experience with various chromatographic techniques including RP, IP-RP, AEX, and SEC
  • Ability to construct and release content assay data from calibration curves
  • Experience with quantitative HPLC, UHPLC or UPLC with UV, FLR, CAD, ELSD detectors
  • Experience with instrumentation housekeeping and maintenance, especially metrology of analytical HPLC instrumentation and interfacing with vendors PM agreements

Preferred:
  • Experience with quantitative HPLC, UHPLC or UPLC with UV, FLR, CAD, ELSD detectors
  • Size exclusion LC separation and LC/MS-MS experience
  • Familiarity with oligonucleotide and nucleic acid drug substance or drug product separation and characterization
  • Experience with forced degradation, stability, bridging and other work dictated by protocols
  • Knowledge and experience with technologies such as ELISA, flow cytometry, PCR/other molecular biology-based assays
  • Ability to quickly cross-train on cell-based assays
  • Familiarity with qPCR and capillary electrophoresis
  • Ability to think critically and troubleshoot within a cGXP environment
  • Detail-oriented with strong analytical and organizational skills
  • Ability to work independently and as part of a team
  • Willingness to Interact in a collaborative manner with staff at all levels

Location
  • This position is located at the new Manufacturing Center for Advanced Therapies facility in RTP.

Travel Requirements
  • This position requires little to no travel (0-5%)

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.