• Technician R&D

    Location US-NJ-Bridgewater
    Posted Date 4 weeks ago(5/25/2018 1:58 PM)
    ID
    2018-2169
    Company
    Kashiv Pharma LLC.
  • Overview

    The Technician position fulfills a critical role in daily execution of trials to successful pilot/scale-up/ANDA batches and commercial batches. This individual leads and manages all floor execution using his or her advanced technical skills, management with strong working knowledge of cGMP compliance. This individual communicates well verbally with good writing and critical analysis skills and presents process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors and formulation scientists.

    Responsibilities

    • Execute trials to pilot/scale-up/ANDA and commercial batches, including process optimization of oral dosage form, liquids and parenteral unit operations using FDA’s quality by design and well-experimental design approaches.
    • Communicate well verbally with good writing and critical analysis skills and present process optimization and trouble-shooting activities, findings and recommendations to his/her supervisors.
    • Have a strong working knowledge of cGMP compliance.
    • Possesses advanced technical skills, time management and communication competencies, and a commitment to innovation and efficiency.
    • Excels at training, mentoring, and supervising junior technical professionals.
    • Is up-to-date on recent advances of manufacturing equipment and operation.
    • Performs other functions as required or assigned
    • Complies with all company policies and standards

    Qualifications

    Position Requirements and Qualifications

     

    The employee should have at least associated degree or equivalent in related pharmaceutical sciences with at least 3+years of experience.

     

    Specialized Knowledge and Skills

     

    • Granulation: Roller Compaction, Extrusion, Hot Melt Extrusion, Wet Granulation, Fluid Bed Granulation, Rotor Granulation
    • Compression/Encapsulation:Bi-Layer, Spray Lubrication, Fette, Korsch, Manesty, H&K, Zanasi, MG, Carver Lab Presses
    • Coating: Fluid Bed, Wurster, & Pan
    • Liquid Filling: Liquid and Powder Fillers, Stoppering and Aluminum Sealing Machines
    • Sterile Area Processing: Clean room gowning practices. Sterile area manufacturing. Sterilization of machine parts and packaging components
    • Computer Skills: Microsoft Office (Word, Excel, PowerPoint, Outlook)

     

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