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Senior Research Associate, 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 support clinical development and commercialization of antibody therapeutics. The Research Associate will bring a strong technical background including development, transfer, and qualification of analytical methods, characterizing physicochemical attributes of therapeutic candidates, developing new and orthogonal methods for extended characterization, and evaluating orthogonal and complementary technologies to improve throughput. This position will also contribute to tech transfer to clinical and commercial stage CRO's/CMO's and may contribute to managing external CRO's who may develop and implement methods for routine testing and extended characterization.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
    • A bachelor's or master's degree in Chemistry, Biochemistry, Biology, Analytical Chemistry, or a related field with a minimum of five years of biotechnology and/or pharmaceutical industry experience
    • Experience developing robust HPLC (SEC, RP, peptide map, CEX, etc.) and/or CE-based (CE-SDS, cIEF, icIEF) methods
    • Experience with troubleshooting and optimizing methods
    • Experience with routine lab equipment and methods, including preparing buffers, measuring pH, UV absorbance, quantifying particulates, etc.
    • Strong understanding of technical principles of chromatographic and/or electrophoretic methods
    • Capable of interpreting data and communicating and presenting results to peers and management
    • Demonstrated written and verbal communication skills with peers and management
    • Experience and proficiency with Waters Empower and/or Sciex 32 Karat software is highly desired
    • Experience with technology transfer to third parties is desired#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 , Senior Research Associate, Analytical Development, Other , Seattle, Washington

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