Quality Control Associate
- Employer
- Precision BioSciences, Inc.
- Location
- Durham, NC, United States
- Start date
- Aug 20, 2019
View more
- Discipline
- Quality, Quality Control
- Required Education
- Associate Degree
- Position Type
- Full time
- Hotbed
- Bio NC
Job Details
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.
Company
Precision BioSciences, Inc. (Nasdaq: DTIL) is a clinical stage gene editing company developing in vivo gene editing and ex vivo allogeneic CAR T therapies with its highly precise and versatile ARCUS genome editing platform. ARCUS uses sequence-specific DNA-cutting enzymes, or nucleases designed for gene knock out, as well as highly sophisticated edits for gene insertion and/or gene repair. Precision’s in vivo gene editing pipeline consists of wholly-owned preclinical candidates for primary hyperoxaluria type 1 (PBGENE-PH1), familial hypercholesteremia (PBGENE-PCSK9) and chronic hepatitis B (PBGENE-HBV). It has also partnered with Lilly to develop candidates for Duchenne muscular dystrophy and two other programs targeting the liver and CNS. Precision’s allogeneic CAR T pipeline consists of multiple investigational candidates in early-stage clinical trials, including its first and second generation CD19 targeting candidates PBCAR0191 and PBCAR19B for relapsed and/or refractory (R/R) non-Hodgkin and B-cell lymphoma patients. Precision has also prioritized development of PBCAR269A, its BCMA targeted candidate in combination with a gamma secretase inhibitor for R/R patients with multiple myeloma. Precision BioSciences and its in-house manufacturing facility for AAV, mRNA, and CAR T cells is based in Durham, North Carolina. For more information about Precision BioSciences please visit www.precisionbiosciences.com
Stock Symbol: DTIL
Stock Exchange: NASDAQ
- Website
- http://www.precisionbiosciences.com/
- Phone
- 919-314-5512
- Location
-
302 East Pettigrew Street
Durham
North Carolina
27701
US
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