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Analytical Scientist

Company: Precision BioSciences
Location: Durham
Posted on: August 16, 2019

Job Description:

The Scientist position involves collecting data via HPLC and Mass Spectrometry to characterize drug substances and drug products and their product and process impurities. Data may also be collected from analyses of processed animal serum and cells in culture. Analytical assay data collection using other formats such as plate readers, LC, or gel based assays may also be assigned. 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.

  • Implement and maintain HPLC based assays for drug substance and drug product testing
  • Perform routine purity and content testing of samples from Research and Process Development teams
  • Support analytical method pre-qualification activities
  • Participate in tech-transfer activities to manufacturing as required Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Required:
    • Experience with HPLC testing of products in a cGXP environments
    • Experience with various chromatographic techniques, including RP, IP-RP, AEX, and SEC
    • Ability to construct and release content assay data from calibration curves
    • Experience in the development of quantitative HPLC or Mass Spectrometry based assays Preferred:
      • Analytical method pre-qualification experience using HPLC, UHPLC or UPLC with UV, FLR, CAD, ELSD detectors
      • Familiarity with oligonucleotide and nucleic acid drug substance or drug product separation and characterization
      • Experience with development, pre-qualification and technical transfer of assays, including testing protocol execution
      • Familiarity with Mass Spectrometry analyses
      • Size exclusion LC separation experience
      • HILIC development experience for adaptation of assays to LC/MS-MS
      • Experience with development of hydrophobic small molecule assays with detection by CAD or ELSD
      • Experience with Analytical testing of drug product or drug substance material from Phase 3 or commercial products
      • Prior experience in the pre-qualification of analytical assays for Technology Transfer purposes, which may include the adaptation of analytical method work instructions into standard operating procedures (SOPs) and finalizing Pre-qualification Plans and protocols
      • Familiarity with Instrumentation housekeeping and maintenance, especially metrology of analytical HPLC and Mass Spectrometry instrumentation, including the collection of calibration data and GLP based instrumentation recording and interfacing with vendor PM agreements
      • Experience with Forced degradation, Stability, Bridging and other work dictated by Protocols Qualifications The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully. Education/Experience
        • Master of Science degree in Chemistry, Biochemistry, Physical Chemistry or related field, with 5 years industry experience developing analytical testing for commercial or late stage products or equivalent training and experience Travel Requirements
          • The Scientist will be expected to travel to all applicable locations when needed. Location
            • This position is located at the Durham, NC location and is required to work on-site in a laboratory, in order to be most effective, at managers discretion. Precision BioSciences mission and vision is to translate the worlds most powerful genome editing technology into greatly needed products throughout the life sciences, by being the conduit through which the greatest genome engineering challenges are solved. Precisions wholly proprietary ARCUS genome editing platform enables the production of highly specific nucleases that can insert, remove, and modify DNA at essentially any location in a complex genome. Through our ARCUS platform, we are developing genome editing-based products to address critical needs in oncology, genetic disease, agriculture, and beyond. For additional information, please visit 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.

Keywords: Precision BioSciences, Durham , Analytical Scientist, Other , Durham, North Carolina

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