• Principal Scientist, AR&D- Mass Spectrometry

    Location US-NJ-Bridgewater
    Posted Date 1 week ago(10/12/2018 1:27 PM)
    ID
    2018-2184
    Company
    Kashiv Pharma LLC
  • Overview

     

    Here at Kashiv Pharma, our vision is to become a world-class premier drug delivery, development, and specialty pharmaceutical company. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Kashiv Pharma offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Principal Scientist, AR&D- Mass Spectrometry to be based out of Piscataway, NJ.

     

    The successful candidate will be responsible for development innovative analytical methods to test biological drug substances and drug products, the planning and execution of studies to support formulation development and manufacturing process development, analytical similarity studies, and release/stability testing using LC-MS-based detection.  The incumbent must have the experience working in authoring SOPs and technical reports suitable for review by health authorities and mentoring other scientists. The successful candidate will be a highly motivated, well-organized, detailed-orientated scientist with the ability to work effectively in a fast-paced and multi-disciplinary environment.

    Responsibilities

    • Participate and lead in technology development and implementation by exploring novel concepts and innovative workflows to expand the group’s mAb analytical capabilities
    • Participate in all phases of mass spectrometry laboratory operations including technology evaluations, the development of sample preparation and separation methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
    • Application of regulatory guidance for assay development, data analysis, and biosimilarity testing.
    • Development of bioassays for characterization and product release: binding, potency, effector function, downstream signaling, reverse-signaling, etc.
    • Support drug substance and drug product manufacturing process development
    • Transfer of analytical methodologies to other laboratories.
    • Participate and/or lead cross-functional project teams.
    • Author reports suitable to support regulatory filings and responses to inquiries from regulatory authorities.
    • Represent the company in discussions with external parties (conferences, regulatory meetings, CROs/CMOs, business partners)

    Qualifications

    • Familiar with ICH guidelines and USP/EP pharmacopeia requirements
    • A strong theoretical understanding and experience in protein chemistry
    • Expertise in development, characterization, and implementation of biomarker assays based on quantitative protein mass spectrometry for drug development.
    • Experience and knowledge in operation of modern triple quadrupole and ion trap/orbitrap mass spectrometers and associated control and data analysis software systems.
    • Knowledge and application of complex sample preparation methodologies as applied to quantitative protein mass spectrometry workflows.
    • PhD. in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry with 10+ year’s relevant industrial experience.

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