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Research Associate, Analytical Ops

United States - California - Foster CityProcess/Product Development & OperationsRegular

Job Description

Job Responsibilities:

  • Conduct GMP analysis following written procedures using analytical techniques such as appearance, water content, dissolution, disintegration, liquid chromatography, DSC, particle size, XRPD, UV-Vis spectroscopy, etc.
  • Begins to learn and apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis
  • Review data and results of testing to ensure compliance to appropriate specifications and protocols
  • Perform stability data trending
  • Write non-test lab event with guidance
  • Support laboratory investigations and deviations
  • Write simple protocols and reports
  • Participate in group meetings.  May present data or prepare information for others to present.
  • Support compendial review program as needed

Essential Education & Experience:

  • 0-2 years of experience with BS degree in a related scientific discipline or 0-1 years of experience with MS degree in a related scientific discipline
  • Be able to follow written procedures and work independently in a GMP setting
  • Strong organizational, planning, problem solving skills
  • Excellent communication and interpersonal skills
  • Working knowledge of Microsoft Office software to perform required job functions

Preferred Experience:

  • Prior experience working in a QC/GMP laboratory
  • Working knowledge in Lab Information System and Part 11 software including ELN, Empower, LabX, LIMS, LES, GTrack, and SDMS
  • Experience in stability and testing of biologics, although not required, a plus