Precision Biosciences, Inc. seeks Scientist II, CMC-Analytical Development in Durham, NC.
Support chimeric antigen receptor (CART) analytical development programs. Responsible for assay development, in-process testing, and data collection to characterize drug substances and drug products and their product and process impurities. Develop and/or improve plate-based molecular and cell-based assay execution and analysis. Perform aseptic cell culture with primary mammalian cells or cell line. Develop and/or improve plate-based immunochemistry-based assay execution and analysis. Develop and/or improve HPLC based assays for drug substance and drug product testing. Perform routine purity and content testing of samples from Research and Process Development teams. Drive and support analytical method pre-validation strategies and activities. Participate in tech-transfer activities to manufacturing as required. Analytical assay data collection using formats such as HPLC, MS, plate readers, particle sizers, and/or cell culture assays. Revision of work instructions, SOP’s, Method Development Reports and other GXP documents. Provide guidance and indirect oversight for research associates in execution of the above efforts.
Requirements: Master’s degree in Biotechnology or Biological Sciences plus 4 years of experience in the job offered or related position within the biopharmaceutical/immunotherapeutic development industry.
Must have 2 years of experience with:
Culturing primary human T cells and mammalian cell lines.
Assay automation platforms.
Statistical and DoE software (GraphPad Prism, JMP).
Analytical method pre-qualification experience using HPLC, UHPLC or UPLC with UV, FLR, CAD, ELSD detectors.
Instrumentation housekeeping and maintenance, especially metrology of analytical HPLC and Mass spectrometry instrumentation, including collection of calibration data and GLP based instrumentation recording and interfacing with vendor PM agreements.
Forced degradation, Stability, Bridging and other work dictated by Protocols.
Must have experience with:
Handling and analysis of large molecule biotherapeutics, cells, and nucleic acids
Molecular assays (ELISA, PCR, dPCR), immunochemistry assays (including ELISA, MSD and Luminex) and cell-based assays (ADCC, Potency assays).
HPLC and MS testing of products in a cGXP environments.
Various chromatographic techniques, including RP, IP-RP, AEX, and SEC.
Constructing and releasing content assay data from calibration curves.
Development of quantitative and qualitative HPLC- or Mass Spectrometry- based assays.
Protein, AAV or nucleic acid drug substance or drug product separation and characterization.
Size exclusion and ion-exchange HPLC separation.
Drug substance and drug product release testing methodologies.
Analytical testing of drug product or drug substance material from Phase 3 or commercial products.
Pre-qualification of analytical assays for Technology Transfer purposes including adaptation of analytical method work instructions into standard operating procedures (SOPs) and finalizing Pre-qualification Plans and protocols.
Domestic travel required 5% of the time. Submit resumes online at https://precisionbiosciences.com.
**Please note, Precision BioSciences mandates COVID-19 vaccination of all employees. Accommodations may be made in accordance with applicable law.
Precision BioSciences, Inc. (Nasdaq: DTIL), is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. This isn’t just a statement supporting the products that we’re developing – it’s a statement that speaks to our collective desire to do our part in improving the lives of those around us. ARCUS is a highly specific and versatile genome editing platform designed with therapeutic safety, delivery, and control in mind. Using ARCUS, Precision is developing allogeneic CAR T and in vivo gene correction therapies for cancer and genetic diseases. Our team includes pioneers in genome editing, leaders in business, and a full staff of talented and committed people who are excited to be a part of medical and scientific breakthroughs. For additional information, please visit www. precisionbiosciences.com
Precision BioSciences actively fosters an inclusive environment to ensure we attract and retain the best talent; we value diversity of life experiences and perspectives; and we encourage innovation in pursuit of our mission. We provide 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.