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    Stability Scientist - New Brunswick, United States - TSR Consulting Services, Inc.

    TSR Consulting Services, Inc.
    TSR Consulting Services, Inc. New Brunswick, United States

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

    Our client, a leading pharmaceutical company is hiring a Stability Scientist on a contract basis. Please only local candidates to New Brunswick NJ. 8 years of relevant work experience required in a Pharmaceutical environment.

    Work Location: New Brunswick NJ

    Pay: $77-79/hour W2

    Required Skills:


    • 8+ years of experience in Stability Program Management for small molecules (oral and sterile product)


    • Strong understanding of stability ICH guidelines and cGMP regulation


    • Very good experience on New Product Introduction


    • Very good understanding on Regulatory CMC , US/EU/ROW submission requirement for stability


    • Hand on experience on handling QC Deviation OOS / OOT, authorship , interpret results


    • Responsible for stability product strategy and oversight of product stability

    programs for commercial small molecules Drug Substances and Drug Products Oral and Sterile


    • Activities include those associated with product stability strategy, stability program requirements, authoring / approving stability protocols, and preparation, review and approval of stability reports and regulatory filings


    • Participates on transfer team for new products to internal and external sites (as required), reviews registrational stability studies and conducts gap analysis against Global Manufacturing & Supply requirements


    • Develops stability data where gaps exist


    • Develops and maintains expertise on the overall stability performance of products manufactured in the global supply chain, including maintaining a working knowledge of the attributes that impact the products' performance/stability profile


    • Serves as stability representative on project teams covering post-approval changes, designs and executes required premarket stability program in support of the change


    • Perform change control impact assessments and document the stability assessment in change controls


    • Review and endorse change controls as an expanded reviewer


    • Initiate change controls related to stability operations


    • Provide the technical requirements in a Master Stability Protocol, review and approve study specific protocols and /or batch enrollment forms


    • Responsible for the handling of annual commercial stability program for assigned products in coordination with sample management groups


    • Authors stability sections of CTD dossiers for post-approval filings, annual reports, product renewals, Annual Product Stability Reviews, and stability related responses to health authority inquiries


    • Serves as stability representative for OOT/OOS investigations, Market Action Fact Finding, and other investigations related to potential quality issues and/or deviations from standards


    • Leads work activities involving Change Controls and CAPA's


    • Expert knowledge and understanding of stability ICH Guidelines (Q1A, Q5C)

    and associated policies, directives and guidance documents


    • A thorough knowledge of cGMP regulations as referenced in The Code of Federal

    Regulations (21CFR) and their specific application to stability programs in a

    pharmaceutical manufacturing facility


    • Expert Knowledge of US/EU/ROW Requirements, Corporate Directives and

    industry best practices


    • Knowledge of Drug Substance and Drug Product manufacturing and good

    understanding of analytical and/or Microbiology methods


    • Very good skills to drive development of technical or scientific initiatives for

    solving complex problems/issues; recommending and drive science-based

    decisions/ implementation of solutions


    • Experience with authorship and able to critically review investigations,

    interpret results, and generate technical conclusions consistent with Quality

    management principles


    • Good Knowledge of evaluation and interpretation of stability data using

    statistics software


    • Review data and demonstrated ability to recognize anomalous trends or results


    • Significant experience on health authorities inspections on stability programs

    79271

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