Scientist III, Gene Therapy Analytics
- Employer
- Precision BioSciences, Inc.
- Location
- Durham, NC, United States
- Start date
- Oct 19, 2020
View more
- Discipline
- Science/R&D, Biotechnology, Genetics
- Required Education
- Doctorate/PHD/MD
- 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.
- 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.
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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