• Analytical Chemist III

    Job Locations US-MA-Bedford
    Posted Date 2 weeks ago(11/6/2018 10:35 AM)
    Job ID
    2018-1154
    # of Openings
    1
    Category
    Quality
  • Overview

    Execute on moderately complex research and development activities as assigned by management, including analysis of drug samples by HPLC. Work with project team members to support development of drug delivery platform products. Participate in formulation support, method development and validation, the maintenance and troubleshooting of HPLC equipment, and coordinate outsourcing of testing and method development with vendors.

     

    Responsibilities

    • Responsible for product release testing per specifications for incoming materials and final product
    • Support the method development and validation activities in drug delivery development as requested
    • Lead method improvements and optimization exercises to improve analytical throughput (i.e. cost reduction)
    • Prepare and analyze samples according to established test methods
    • Responsible for analytical chemistry testing using HPLC, UPLC, Karl Fischer, etc.
    • Participate in data review and write data analysis reports
    • Calibrate instrumentation on a scheduled basis and troubleshoot equipment and test method issues  
    • Lead test method characterization and validation activities
    • Coordinate with supervisor on scheduling of testing reagents and products
    • Coordinate external outsourcing and testing
    • Support QC Management with tracking and trending product release and incoming material testing data
    • Other duties as assigned

    Qualifications

    • Bachelor's Degree in Chemistry or related field
    • Minimum of 5 years of related experience
    • HPLC experience
    • Method Validation experience required; Method Development experience preferred
    • Operation in a GMP industry preferred
    • Knowledge of safe laboratory practices
    • Strong verbal and written communication skills. Knowledge of CFR 210, 211, USP and FDA/ICH guidance
    • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
    • Demonstrates good judgment in selecting methods and techniques for obtaining solutions
    • Ability to network with senior internal and external personnel in own area of expertise  

     

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