West-Ward Pharmaceuticals

  • Research Chemist – Elemental Analysis Subject Matter Expert

    Job Location US-OH-Bedford
    Posted Date 2 weeks ago(4/12/2018 5:18 PM)
    Job ID
    2018-4452
    Job Function
    Research and Development
  • Overview

    This position is responsible for the quantitation of metallic and non-metallic elements in pharmaceutical preparations and samples in support of existing and new product development. This may include, but is not limited to, residual catalysts and metallic scavengers in drug substances, excipients, glass and polymeric container closure systems as well as elemental impurities contributed by process equipment during manufacture. This position will also support/assist in the development of methods of analysis (chromatographic, spectroscopic and other) for pharmaceutical products when not engaged in elemental studies.

    These tasks require expertise in the techniques of Inductively-coupled plasma-mass spectroscopy (ICP-MS), Inductively-coupled plasma-optical emissions spectroscopy (ICP-OES) and atomic absorption (AA)/atomic absorption-graphite furnace (AA-GF) spectroscopy. This position requires expertise in the techniques of dissolution of the aforementioned substances/materials in order to prepare samples for analyses as well as sampling and operation of AAS and ICP-MS instrumentation. Specifically, this includes various microwave assisted extraction techniques including pyrolyzers and acid digestions. The candidate selected should be able to develop and validate analytical methods of digestion and analysis for elemental components in both organic and inorganic matrices. Additionally, the candidate selected will support collaborative efforts within Hikma and outside (Contract labs) for the expressed purpose of ensuring compliance with all applicable regulatory guidances related to the presence of elemental impurities in drug substances and finished dosage forms. This will include the development of risk based strategies (FMEA) and associated documents. Familiarity with relevant ICH and USP guidances is preferred.

    Responsibilities

    • Day to day operations and/or supervision of operations related to the analysis of elemental impurities utilizing Agilent 7000 series ICP-MS.
    • Collaboration with formulation and process scientist to identify and coordinate elemental studies supporting the development of new (generic) drug products.
    • Maintenance and troubleshooting of instrumentation including remote/on-site support of similar instruments of analysis located at manufacturing sites.
    • Development and validation of new analytical techniques for the analysis of elemental impurities.
    • Development and validation of new analytical techniques (chromatographic, spectroscopic and other) for the analysis of pharmaceutical preparations.
    • Coordination of documentation associated with the demonstration of continued compliance with applicable regulatory guidances related to the presence of elemental impurities in pharmaceutical preparations (FMEA risk assessments and associated documents)
    • GMP compliant documentation of all development and testing activities including the reporting of data related to the above activities.
    • Training and mentoring junior scientists in support of departmental and corporate objectives related to the development of new (generic) drug products.
    • Travel 10% of the time.

    Qualifications

    • Requires a bachelor’s degree in chemistry or closely related field and at least 10 years of pharmaceutical or related laboratory experience, or
    • Master’s degree in chemistry or closely related field with 6 years of pharmaceutical or related laboratory experience, or
    • Ph.D. in chemistry or pharmaceutical science or closely related field and 2 years of pharmaceutical or related laboratory experience.

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