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Project Manager, Bioprocess Analytics

Key Responsibilities:

  • Project Manager, Bioprocess Analytics will focus on various separation science platforms such as HPLC/UPLC and cIEF using a variety of detection modes. Analytical method support, optimization, qualification, and troubleshooting are required to support programs in early and late stage research through the POC and Development stage.
  • Support of other analytical methodologies such ELISAs and other binding assays, impurity assays such as detection of host cell proteins, and residual impurities based on project needs.
  • Provide subject matter expert technical support of separation-based assay qualification in a nonGMP setting following ICH guidelines.
  • Mentor junior analysts to ensure timely completion of testing/support assignments.
  • Interface with other organizations within the Creative Biogene network.

Basic Qualifications:

  • M.S. in Analytical Chemistry, Biochemistry, or related discipline.
  • Strong background in UPLC/HPLC, including familiarity with instrumentation from different vendors, excellent instrument and method troubleshooting skills, as well as knowledge of various data analysis approaches are required.
  • Experience in electrophoresis-based technologies (e.g. capillary electrophoresis, cIEF)
  • Proficiency with the use of tools such as Chemstation, OpenLab, and/or Empower is a must.
  • Experience in the qualification of analytical methods following ICH guidelines.
  • Experience in evaluating/developing new technologies independently with the ability to propose/design implementation strategies if deemed appropriate.
  • Experience with ELISAs and other binding assays and/or spectrophotometric assays is a plus.
  • The successful candidate is expected to be an independent, self-driven team player who is ready to provide guidance and mentorship to junior staff as a direct supervisor or in a matrix setting to help nurture their career growth.

Creative Biogene is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

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