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  • Msat Medical Devices Injectables Technician - Madrid - Mabxience

    Mabxience
    Mabxience Madrid

    hace 1 semana

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    Descripción

    Job Title: MSAT Medical Devices Technician

    We are seeking a skilled MSAT Medical Devices Technician to join our team at Mabxience, a company specializing in the development and manufacture of biosimilar medicines.

    Responsibilities

    • Act as drug-device combination expert, including planning and coordination of medical devices manufacturing processes for new molecules under development in external Contract Development and Manufacturing Organizations (CDMOs).
    • Collaborate with mAbxience's development team and third-party companies in device development stages as well as regulatory submissions.

    Key Responsibilities

    • Search and select new technologies, suppliers, and CDMOs for the development and assembly of medical devices.
    • Contribute to the generation of medical devices Design History File (DHF) and related documentation.
    • Author tech transfer protocols and reports for medical device manufacturing in selected CDMO.
    • Provide scientific support during medical device development, assembly process tech transfer, and validation.
    • Assess deviation root cause and impact, as well as implement Corrective Action Preventative Actions (CAPAs).
    • Coordinate medical device assembly process implementation and validation at CDMO.
    • Generate risk assessments, process descriptions, bill of materials, manufacturing procedures, and sampling plans compliant with regulatory standards and guidelines.
    • Support the regulatory submission process, including SME input and/or revision of relevant dossier sections and participation in regulatory agency interactions.
    • Lead the evaluation and implementation of process improvements and scale-ups.
    • Assist in regulatory variation procedures.

    Requirements

    • University degree in biotechnology, biochemistry, chemical engineering, or a related field.
    • Fluent English language proficiency.
    • Knowledge of other languages is an asset.
    • At least 5 years of experience in Operations, R&D, MSAT in development and manufacturing of medical devices, mainly prefilled syringes (PFS) coupled with needle safety devices (NSD) and autoinjectors (AI).
    • Open to travel.
    • Experience in project management and scale-up to industrial manufacturing, work in Good Manufacturing Practice (GMP) environment, DHF generation, and regulatory filing (ICH, EMA, and FDA requirements), tech transfer, process validation.

    About Us

    mAbxience is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.


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