• Scientist III Bioassay, AR&D

    Location US-NJ-Bridgewater
    Posted Date 2 months ago(10/12/2018 1:31 PM)
    ID
    2018-2185
    Company
    Kashiv Pharma LLC
  • Overview

    The Scientist III Bioassay will be responsible for phase specific analytical method development and sample testing required for functional characterization of biologics through various phases of biosimilar development. Additional responsibilities include support of method transfer to QC laboratories and liaising with CRO laboratories. Techniques employed include but are not limited to cell based assays, ELISA and SPR binding assays. Experience with flow-cytometry and BLI binding assays is a plus. The candidate must have experience authoring SOPs and technical reports. The successful candidate will be a highly motivated, well-organized, and detail-oriented scientist who can work effectively in a fast-paced and multi-disciplinary environment.

    Responsibilities

    • Development of bioassays for characterization and product release: binding, potency, effector function assays, downstream signaling, reverse-signaling, etc.
    • Support drug substance and drug product manufacturing process development
    • Elucidation of structure/function relationships for biologic therapeutics
    • Transfer of analytical methodologies to other laboratories
    • Maintain a detailed and well-organized record of all laboratory activities
    • Author SOPs and technical reports
    • Participate and/or lead cross-functional project teams
    • Represent the company in discussions with external parties as needed
    • Participate in lab maintenance activities as needed

    Qualifications

    • Strong experience in analytical method development and validation
    • Firm understanding of cellular pathways and mechanisms of drug action
    • Familiar with ICH guidelines and USP/EP pharmacopeia requirements
    • A strong theoretical understanding and experience in protein chemistry
    • Strong experience in analytical method development and validation
    • Firm understanding of cellular pathways and mechanisms of drug action
    • Familiar with ICH guidelines and USP/EP pharmacopeia requirements
    • A strong theoretical understanding and experience in protein chemistry
    • Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 12 years of industry experience

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      Or Master’s Degree in Biochemistry, Biotechnology, Biology with 10 years of industry experience

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      Or Ph.D. in Cell Biology, Biochemistry, Biotechnology, Biology with 5-8 years of experience

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