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Sr. Research Associate, Analytical Development, Tustin, CA

Company: Kelly Services
Location: Mission Viejo
Posted on: April 10, 2021

Job Description:

Sr. Research Associate, Analytical Development, Tustin, CAPosition Type:--Direct HireWork Schedule and Hours:Any scientific staff member can expect to work overtime, including during the weekends. Off-site meetings with clients and regulatory agencies are a usual occurrence.Summary/Objective:The Analytical team is seeking an experienced Sr. Research Associate ("RA") who is interested in pursuing a career in developing protein biologics. The primary focus of the Sr. RA will be to develop Cell-based, ELISA, HPLC, and/or LC-MS methods. The incumbent will work under the guidance of analytical scientists and with process development scientists to identify and characterize protein biologics. This position will interface with the Quality Control testing group as methods are transferred into that group for cGMP testing and may interface with external clients.Essential Duties and Responsibilities--include the following: (other duties may be assigned)

  • Perform and review routine wet chemistry/raw material assays and ELISA/cell-based immunoassays, electrophoresis (SDS-PAGE/IEF) and HPLC.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • May train/supervise the experimental work of more junior analysts and may be a member of interdepartmental/tech transfer teams.
  • Develop, review, revise and write test methods, standard operating procedures and may perform trending analysis.
  • May be designated as study lead for validation projects, investigations and method development projects.
  • Previous experience in either HPLC/CE or Potency/ELISA assay methodologies is required.
  • Knowledgeable of company cGMPs as well as industry regulations that apply to job functions. Participates in regulatory inspections.
  • Support continuous improvement initiatives.Required Education and Experience:
    • At least a Bachelor of Science degree in the Biological or Physical Sciences, preferably Biochemistry, Chemistry, Biology.
    • 4-6 years industry experience working in a QC or Analytical lab (with a BS degree) or
    • 2-4 years industry experience working in a QC or Analytical lab (with a MS degree)
    • Analytical testing and equipment utilizing analytical biochemistry methods
    • Writing reports/procedures/specifications
    • GMPs and regulatory audits
    • Potency/ELISA and/or HPLC experience is essential.
    • Should also have experience with most if not all of the following: protein characterization, electrophoresis, chromatography, aseptic techniques, cell culture, LAL and assay validation/qualification.Please note, industry experience should relate to--antibody/large molecule manufacturing--and demonstrated working knowledge of scientific principles.Why Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Mission Viejo , Sr. Research Associate, Analytical Development, Tustin, CA, Other , Mission Viejo, California

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