Hikma Pharmaceuticals USA Inc.

  • Scientist I, Analytical Development

    Job Location US-OH-Columbus
    Posted Date 2 weeks ago(1/5/2019 1:41 PM)
    Job ID
    2018-5036
    Job Function
    Research and Development
    Shift
    Columbus First Shift
  • Overview

    Conducts chemical and physical analyses in support of the development of a manufacturable multi-source pharmaceutical product. Provides analytical support for the release of registration materials in support of regulatory submissions. Assists analytical method validation and transfer activities.

    Responsibilities

    • Performs the assigned analytical tasks in support of product development, registration lot release, pre and post regulatory submission activities. Performs activities within the assigned time-lines and in compliance with cGXP's, and company practices and procedures.
    • Follows work instructions, SOPs and company practices. Documents analytical activities and results accurately, in a timely manner and right-first time and maintains integrity of data.
    • Performs assigned tasks in support process changes (e.g. processes, procedures, etc...) within the assigned time-lines.
    • Communicates effectively with peers and supervisor about the status of the assigned tasks, maintaining supervisor constantly updated.
    • Follows written analytical procedures. Identifies execution challenges of analytical methods and support trouble shooting activities.

    Qualifications

    • BS/BA in a scientific discipline.
    • Prior experience in pharmaceutical industry is preferred.

    • Experience with the following analytical techniques is preferred:

      • For API: UV/Vis, IR, pH meter, wet chemistry techniques, GC and HPLC.

      • For Product: UV/VIS, dissolution, pH meter, wet chemistry techniques, and HPLC.

    • Experience in c-GXP analytical laboratories is preferred.

    • Inhalation Testing experience is preferred.

    • Experience with dry powder inhalers preferred.
    • Experience with data acquisition software is desirable.

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