• Analytical Chemist II

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(2/7/2019 10:07 AM)
    Job ID
    2019-1194
    # of Openings
    1
    Category
    Other
  • Overview

    The Analytical Chemist II will be responsible for participating in the development and qualification of 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.

    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
    •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
    •Conduct release testing under GMP conditions for clinical drug product.
    •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
    •3+ 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 or as a part of a team
    •Comfortable working in a fast paced, high pressure environment
    •Proficient computer skills including Empower and statistical analysis software

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