Hikma Pharmaceuticals USA Inc.

  • Scientist II, Analytical

    Job Location US-OH-Columbus
    Posted Date 1 week ago(12/4/2018 6:54 PM)
    Job ID
    2018-4994
    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. Provides constructive feedback for methodology improvements, assist analytical method validation, development, and transfer activities.

    Responsibilities

    • Performs the assigned analytical tasks with minimum supervision 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, regulatory requirements and company practices and procedures.
    • Supports analytical method development, validation and project support. Identifies technical challenges during analytical method development and perform method trouble shooting. These activities will be performed under supervision.
    • Proactively participates in activities in support of process changes (e.g. processes, procedures, etc...). Mentors peers on instrumentation and analytical methods.
    • Follows work instructions, SOPs, company practices and regulatory guidances/regulations. Documents analytical activities and results accurately, in a timely manner and right-first time. Reviews and checks analytical data generated by peers and maintains integrity of data.
    • Communicates effectively with peers, supervisor, management and internal customers about the status of the assigned activities, , maintaining supervisor constantly updated.

    Qualifications

    • MS in a scientific discipline with a minimum of 2 years experience, or
    • BS/BA in a scientific discipline with a minimum of 4 years of experience.
    • For API: experience in HPLC is required. Experience in one of the following GC, particle size, wet chemistry, and DSC/TGA is preferred.
    • For Product: experience in HPLC is required. Experience in one of the following GC, particle size, dissolution, droplet size, AA, and DSC/TGA is preferred.
    • Practical Knowledge of the critical functions/variables of the analytical techniques listed is also required.
    • Experience with data acquisition software is desirable.
    • Knowledge of the most current FDA/ICH guidance’s and national Pharmacopoeias is preferred.

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