Bausch Health

  • Research Scientist - Analytical

    Location US-NY-Rochester
    Job ID
    12316
    Category
    R&D
    Pos. Type
    Full Time
  • Overview

    The primary role of this position is to support the development, validation, implementation and trouble-shooting of analytical methods and the collection of data to set specifications applicable to new or existing generic pharmaceutical drug products. 

    Responsibilities

    • In order to assure the development of appropriate testing methods and strategies, the individual is expected to exhibit/demonstrate an understanding of the behavior of molecules in a chemical and/or physical environment.
    • In a timely manner, validate/verify analytical methods (both chemical and physical) to meet development timelines with quality suitable for regulatory submission.
    • Develop physical methods for characterization of drug products – pH, viscosity/Rheology etc.
    • Develop/validate in vitro dissolution methods using different USP apparatus (I, II, IV etc.)
    • Write method validation protocols and reports
    • Perform stability testing of prototype, GLP, and GMP pharmaceutical products in a timely manner.
    • Document findings in laboratory notebooks and reports, as appropriate, in a timely manner.
    • Draft drug substance and drug product specifications acceptable for FDA filing
    • Perform periodic laboratory audits.
    • Assist with general laboratory housekeeping. Maintain and replace inventory of supplies and chemicals, as needed.
    • Write relevant SOPs where needed
    • Assist with general laboratory housekeeping. Maintain and replace inventory of supplies and chemicals, as needed.

    Qualifications

    BS degree with 5+ years of experience or Masters degree with 2+ years of experience or PhD in Chemistry (pref.), or other physical or biological science discipline will be considered. 

    Must demonstrate solid knowledge of the application of common analytical techniques. A working understanding of experimental design and the basics of statistical evaluation is expected.

    Highly desired: Previous laboratory experience involving analytical method development using HPLC for cGMP use (e.g., pharmaceutical method analysis, quality control testing or bioanalytical method development - including development of methods, validation and/or transfer) 

    Desired: Good written and verbal communication skills. Forensic investigations, familiarity with manufacturing processes, statistical inference, physical testing methods (e.g., dissolution, rheology, or particle size). Familiarity with cGMP, GLP, FDA, ICH guidance.

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