• Analytical Chemist III

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(6/5/2018 2:37 PM)
    Job ID
    2018-1077
    # of Openings
    1
    Category
    Product Development
  • Overview

    We are seeking a highly motivated Analytical Chemist III to join our Analytical Development team. The Analytical Chemist III will be responsible for developing and qualifying phase-appropriate analytical test methods to support clinical development of our drug product portfolio. The incumbent will develop and write methods, standard operating procedures, method qualification/validation protocols and reports, as well as engage in trouble-shooting and conducting continuous improvement on existing methods. Additionally, this position is expected to mentor junior colleagues and will likely have a supervisory component.

     

    Responsibilities

    • Develop analytical test methods in support of project requirements
    • Participate in/supervise HPLC/UPLC, GC, and other analytical method development and validations
    • Transfer validated methods to Quality Control
    • Help maintain and troubleshoot analytical instruments
    • Communicate results and observations to the management team
    • Serve as a member of CMC/Project teams as the analytical development representative
    • Mentor and/or supervise laboratory chemists
    • Provide expert interpretation of data and compare results to established specifications or anticipated trends
    • Think creatively, problem solve, and develop innovative solutions based on sound scientific analysis
    • Author SOPs, development reports, study protocols, and validation reports
    • Liaise with contract laboratories performing method development or testing for Ocular Therapeutix

    Qualifications

    • BS or higher degree in Chemistry or Analytical Chemistry; Master’s preferred
    • 7+ years of progressively more demanding small molecule analytical chemistry experience and hands-on experience within the pharmaceutical or biotechnology industry
    • Hands on knowledge of Instrumental analysis techniques, including, HPLC/UPLC, GC, FT-IR, KF. Other techniques (particle size measurements, NMR, GPC, LC-MS, viscometry) are a plus
    • Experience working in a cGMP environment
    • Familiarity with USP and ICH guidelines and incorporation of these requirements into method development and validation
    • Ability and willingness to work as part of a team, assisting colleagues in providing a functional, safe working environment while maximizing laboratory efficiency
    • Ability to execute controlled experiments with a strong attention to detail
    • Driven self-starter with capability to either work independently, as a part of a team, or as a mentor
    • Comfortable working in a fast paced, high pressure environment
    • Proficient computer skills including Empower and statistical analysis software

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