Hikma Pharmaceuticals USA Inc.

  • Scientist IV, Analytical

    Job Location US-OH-Bedford
    Posted Date 3 weeks ago(10/26/2018 3:28 PM)
    Job ID
    2018-4739
    Job Function
    Research and Development
    Shift
    None
  • Overview

    A Scientist IV is responsible for analytical development activities associated with drug product development projects. This individual will be a subject matter expert and will provide knowledge and insight on how to solve complex technical and scientific problems. 

    Responsibilities

    • Lead generic product development activities such as DMF reviews, de-formulation studies, analytical method development, method validation, method transfer, creating specifications and justifications, designing stability studies,
    • Creation of drug substance and drug product specifications, assistance in authoring Module 3 of ICH M4Q submissions, and assistance with analytical portions of deficiency responses.
    • Understands and applies scientific principles and technology, and demonstrates an in-depth knowledge of relevant regulatory requirements and legal requirements.
    • Demonstrates the ability to design novel experiments and to analyze and interpret subsequent experimental results.
    • Demonstrates strong data interpretation capability, research capability and problem solving skills.
    • Demonstrates proficiency in oral communication and technical writing.

    Qualifications

    • In-depth knowledge of method development, method validation, and method transfer.
    • Knowledgeable of ICH, Compendia and regulatory requirements relating to ANDA and 505(B) (2) filing of injectable products.
    • Experienced in establishing specifications/justifications and answering deficiency letters.
    • Advanced level of experience in analytical instruments and wet chemistry, including but not limited to HPLC, GC, UV, FTIR, volumetric/potentiometric auto-titrators and etc.
    • Demonstrates strong computer literacy, trouble shooting, technical writing, multi-tasking, communication, time management, and prioritization skills.
    • Capable of maintaining professional demeanor under stress.

    • Bachelor’s degree in chemistry or closely related field and at least 15 years of pharmaceutical or related laboratory experience, or
    • Master’s degree in chemistry or closely related field with 12 years of pharmaceutical or related laboratory experience, or
    • Ph.D. in chemistry or pharmaceutical science or closely related field and 9 years of pharmaceutical or related laboratory experience.

     

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