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Research Scientist - Analytical

Company: Bausch Health
Location: Rochester
Posted on: September 21, 2019

Job Description:

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.

  • 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.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.

Keywords: Bausch Health, Syracuse , Research Scientist - Analytical, Other , Rochester, New York

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