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    Senior / Project Scientist - Slough, Berkshire, United Kingdom - SRG

    SRG
    SRG Slough, Berkshire, United Kingdom

    2 weeks ago

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    Description

    Job Title:
    Senior Scientist - Global Biopharmaceutical
    Contract: 2.5 year contract

    SRG are working with a Global Biopharmaceutical company to help them find a Senior Scientist to join their busy team.

    Support the development and implementation of the DP CMC development strategy within BCPDS.

    Support the definition of DP processes for different types of formulation (liquid in vials, PFS or other container, solid (either lyophilized or spray dried), and any other more innovating formulation addressing parenteral route of administration or other requirements for clinical development and future commercial manufacture.

    Provide support to ensure the validation of commercial DP processes for late-stage projects.
    Ensure capturing critical process data and allow appropriate analysis of processes.
    Ensure appropriate batch record review to ensure capturing critical process data and allow appropriate analysis of processes.

    Provide support in the completion of the relevant sections of the Product Specification File and CMC regulatory submissions and regulatory briefing documents and ensure appropriate response to questions from authorities.

    Minimum 3 yrs experience in sterile drug product development and/or manufacturing within the pharmaceutical industry is required.
    Knowledge in primary packaging and regulatory requirement is an advantage.
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