• R&D Sr. Scientist I / II

    Location US-NJ-Bridgewater
    Posted Date 3 weeks ago(6/25/2018 1:34 PM)
    ID
    2018-2172
    Company
    Kashiv Pharma LLC.
  • Overview

    Kashiv Pharma is an emerging pharmaceutical research and drug delivery company focused on developing innovative technology platforms and novel drugs with clinical differentiation and a compelling value proposition for patients, physicians, and payers. We have developed a portfolio of proprietary drug delivery technologies to improve the efficacy, safety, compliance, and dosage of low bioavailability drugs where absorption could be limited due to solubility, permeability, and stability problems. Our approach is to understand market needs and develop innovative medicines to improve health outcomes. The pipeline consists of novel drug formulations for preventing drug abuse or misuse, and in improving treatments for severe debilitating diseases. We plan to commercialize our products through licensing, or partnering, or through the creation of our specialized internal commercialization infrastructure. 

     

    Summary

     

    A Sr. Scientist I/II will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument that include HPLC, UPLC, GC, UV/Vis, Mass spectrometer, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with Technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals.  This position is also responsible for designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.

    Responsibilities

         Key responsibilities of the position include, but are not limited to –

     

    • Develop and validation analytical method for drug substances, drug products, and excipients
    • Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
    • Write protocols, reports, methods, standard operation procedure, and submission documents.
    • Provide analytical support for formulation and process development.
    • Perform independent scheduling and coordination of activities
    • Conduct instrument troubleshooting.
    • Analyze analytical data, identify trends and provide recommendation.
    • Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings
    • Train and provide technical guidance to junior scientists.
    • Conduct laboratory investigation and prepare laboratory investigation report.
    • Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.
    • Evaluate and improve existing test methods
    • Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
    • Perform other job related duties as assigned.

    Qualifications

    Position Requirements and Qualifications

    Education and Experience

    • PhD. in analytical chemistry or related discipline with minimum 5+ years’ US pharmaceutical experience or M.S. with minimum 8+ years experience.

    Specialized Knowledge and Skills

     

    • Posses broad analytical chemistry knowledge in HPLC, GC, UV, FTIR and other related analytical technologies
    • Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA regulations.
    • Hands on experience in wet chemistry techniques.
    • Good verbal and written communication skills.
    • Attention to details and accurate record keeping.
    • Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.
    • Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
    • Ability to work under pressure and meet deadlines

    Work Environment & Physical Demands

     

    General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Some travel may be involved.

     

     

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