Lupin Pharmaceuticals (Company Headquarters)

  • Quality Control Chemist, Finished Product

    Posted Date 1 month ago(11/12/2018 12:59 PM)
    ID
    2018-2426
    # of Openings
    1
    Category
    Quality Control
  • Overview

    Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions.  Together these entities make up the generic and branded U.S. business.  Lupin has a significant generic pipeline, and a branded focus on women’s health.  Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of twelve commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams.  Lupin is prided on being people-focused and centered around how impactful we are with our customers.  Dollars are not a measure of success but rather the people we help along the way.

     

    Responsibilities

    The Quality Control Chemist, Finished Product reports to the Finished Product Group Leader.  The primary purpose of the job is to perform testing and make calculated decisions on the acceptability of process validation samples, raw materials, finished products, stability samples, and developmental samples in a regulated laboratory environment in support of timely disposition of manufactured products. Analyze and interpret results in written and oral format.

    • The primary responsibility is to perform routine release tests of raw materials and finished products including wet chemistry analysis, dissolution, content uniformity, assay, particle size distribution, density, water determination by KF, and other tests according to the in-house specifications and methods and USP monographs using classical wet chemistry and instrumental techniques.
    • Perform routine tests like assays, related compounds, chromatographic purity, residual solvents, particle size distribution, Infra-red spectroscopy using different techniques and instrumentation like UV, HPLC, GC, IR etc.
    • Evaluates test results and decides acceptability of the samples based on the test results. Reviewing and releasing of the raw data, documentation and results for certificate of analysis.
    • Write draft technical documents like specifications, analytical methods, method verification protocols and reports, method transfer documents, investigation reports etc.
    • Maintain accurate lab notebooks and complete all related analytical reports, write summaries, and keep proper documentation in compliance with SOPs.
    • Follow SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices. Maintain the laboratories with good housekeeping practices and in compliant with cGMP.
    • Other duties related to departmental activities may be assigned by management based on situation and necessity

    Qualifications

    • Bachelor’s Degree in Chemistry or related scientific field and 3+ years’ industry experience as a Chemist
    • Master’s Degree in Chemistry or related scientific field and 1+ years’ industry experience as a Chemist
    • Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as USP/ICH requirements)
    • Ability to make observations with instruments and analysis techniques
    • Basic knowledge of instrument techniques and software for instruments like HPLC, GC, IR, KF, metrohm titrator, etc.
    • Ability to carry out necessary computations and to draw and interpret graphs.
    • Basic knowledge of method validation, method transfer and method verification of the analytical methods.
    • Knowledge of basic to advance level of computer skills.

    Physical Requirements

    The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. This position may require lifting up to 10 pounds occasionally. Generally work is performed in a laboratory environment.

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