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    Manufacturing Science - Boston, MA, United States - Connexion Systems & Engineering, Inc.

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    Description

    Job Description Title :
    Cell and Gene Therapy Analytical Senior Scientist
    Connexion Systems & Engineering

    Scientist/Scientist position will be part of Analytical Science and Technology (ASAT) team within Commercial Manufacturing & Supply Chain (CMSC) department.

    S/He will provide expertise in assay development and validation and E2E analytical supports to the commercial manufacturing and critical component release for the Cell and Gene therapy (CGT) portfolio.

    Author and/or review technical documents, including method SOP, study protocol and technical report
    Perform data trending analysis
    Excellent technical writing skills are essential
    Hands-on experience and In-depth knowledge of protein and gRNA analysis required
    Experience in Gene and Cell therapy is desirable
    Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept.
    Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing
    Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
    S or above in Biology, Biochemistry, Analytical Chemistry and related fields.

    Minimum 8 years of experience in the pharmaceutical/biopharmaceutical industry or the equivalent combination of education and experience.

    Company Description

    Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike.

    We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

    Connexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike.

    We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

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