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Scientist I, Analytical Development

Company: Kelly Services
Location: Seattle
Posted on: April 9, 2021

Job Description:

Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.OverviewThis position will primarily be responsible for the development, transfer, qualification, and validation of potency bioassays in support of clinical development and commercialization of antibody therapeutics. The incumbent may also contribute to the development, transfer, and qualification / validation of impurity ELISAs and analytical HPLC and/or CE methods to monitor physicochemical quality attributes for both protein and small-molecule therapeutics. The individual will develop and implement methods for characterization, contribute to technology transfer to clinical and commercial stage CROs / CMOs, and provide input to and manage external CROs who may develop and implement methods for characterization, release, and stability testing.Responsibilities--

  • Analytical method development, testing, transfer, qualification, and validation in a GLP and/or GMP environment
  • Troubleshoot typical method and equipment challenges
  • Write standard test methods, technical reports summarizing analytical data, and qualification / validation reports
  • Participate in cross-functional teams as a representative of the Analytical Development group
  • Assists in trouble-shooting CMC-related problems from CROs / CMOs
  • Assists in investigations involving data generated internally and by CROs / CMOs
  • Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
  • Contribute to drafting regulatory submissions
  • Ensures compliance with all applicable regulatory guidelinesQualifications
    • BS, MS or Ph.D. in biology, biochemistry, analytical chemistry, or a related field
    • Demonstrated knowledge and experience developing potency ELISAs for protein therapeutics and interpreting data is required
    • Knowledge and experience transferring, troubleshooting, and validating assays is required
    • Knowledge and experience developing HPLC and/or CE based methods is a plus
    • Small and large molecule experience is desired
    • Demonstrated problem-solving capabilities
    • Knowledgeable in global regulatory CMC documents
    • Familiar with GMPs and qualification / validation practices
    • Experience in biotechnology/pharmaceutical industry required
    • Experience with "start-up" biopharma company desirable
    • Excellent communication, analytical, and organizational skills required#TJP2021_SPECWhy 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, Seattle , Scientist I, Analytical Development, Other , Seattle, Washington

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