Lupin Pharmaceuticals (Company Headquarters)

  • QC Chemist, Raw Materials

    Posted Date 1 month ago(10/16/2018 2:44 PM)
    ID
    2018-2414
    # 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 reports to the Quality Control Manager and is expected to perform testing and decides on the acceptability of the in-process, process validation samples, raw materials, finished products, stability samples and developmental samples in a regulated laboratory environment.  Analyze and interpret results in written and oral format. 

    • The primary responsibility is to perform routine release tests of raw materials (Active ingredient, excipients, colors, flavors) and packaging materials in accordance with established procedures (in-house, Pharmacopoeial, vendor procedures)
    • 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, UPLC, GC, Malvern, IR etc.
    • Perform routine wet chemistry analysis like titration, water content, specific rotation, melting point, identification tests, viscosity, density, LOD, LOI, ROI etc. as per respective monographs and established procedures in a regulated laboratory environment
    • 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.
    • Writing 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.
    • Design and develop test methods, perform experimental tests and evaluates its performances for raw material methods. Establish test specifications, communicates with internal and external customers
    • Perform testing on advanced instrumentation techniques like ICP-MS, Malvern mastersizer 3000, X-ray diffraction techniques.
    • Follow all 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.
    • Evaluation of the technical dossiers of API and excipients, vendor DMF’s, technical documents, literature search etc. as per guidance
    • 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 4+ years’ industry experience as a Chemist
    • Masters Degree in Chemistry or related scientific field and 2+ years’ industry experience as a Chemist
    • Knowledge of current GMP guidance, applicable USFDA and ICH guidelines and regulatory requirements (such as ANDA filing requirements, USP/ICH requirements)
    • Ability to make observations and troubleshoot the issues with instruments and analysis techniques
    • Ability to evaluate the changes in the Pharmacopoeial procedures (USP, EP, BP) technical dossiers, vendor DMF’s, publications.
    • Ability to lead and direct the work of small group of chemists.
    • Advance knowledge of instrument techniques and software for instruments like HPLC, UPLC, GC, IR, metrohm titrator, Malvern, XRD, ICP-MS, etc.
    • Ability to carry out necessary computations and to draw and interpret graphs.
    • Knowledge of method validation, method transfer and method verification of the analytical methods.

     

    Physical Environment

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed