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  • Specialist - Qc Separation Sciences - Dublin - Amgen

    Amgen
    Amgen Dublin

    3 weeks ago

    Amgen background
    Full time
    Description

    Job Summary:

    This Technical Specialist role leads, coordinates, and facilitates lab operations and compliance without direct supervision. They provide technical expertise on method transfers, continuous improvement, and lean culture, with a focus on Right First Time (RFT). The role represents the QC unit by liaising with internal and external customers.

    Key Responsibilities

    • Serve as a Subject Matter Expert (SME) in analytical techniques including HPLC, HIC, CE, UPLC, and Mass Spectroscopy.
    • Plan and perform complex routine and non-routine methods.
    • Provide technical guidance and apply expertise to resolve technical issues independently.
    • Lead training of staff on technical aspects of the job as required.
    • Develop, revise, and implement procedures that comply with regulatory requirements.

    Additional responsibilities include managing project groups, leading high-performing teams, delivering results, qualifying analytical equipment, and coordinating activities related to method transfers and optimization of Separation Methods.

    Requirements

    • Hold a third-level qualification (Degree) in Biology, Biotechnology, or a related discipline.
    • 7+ years of experience in a pharmaceutical/healthcare laboratory.
    • Proven experience of leading teams.
    • Strong background in Separation techniques.

    PREFERRED QUALIFICATIONS:

    • Excellent written and verbal communication skills.
    • Experience with Track Wise, Change Control Systems, EDMQ, and SAP.
    • Knowledge of applicable Regulatory requirements.
    • Experience with Regulatory inspections and interacting with inspectors.

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