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    Project Manager Senior - New Albany, United States - Calsoft Labs

    Calsoft Labs
    Calsoft Labs New Albany, United States

    1 week ago

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    Description
    100% onsite for OH New Albany site.


    Ideal candidate:
    supporting process development. needs to have a biotech, med device, pharmaceuticals wants them to bring 5 years of experience.

    Experience with GMP environment Technical degree preferred:
    Engineering open to chemical, mechanical, etc. Candidate should showcase they have executed projects took ownership full lifecycle. Ideally smart sheets, MS Project, or other PM tools.

    As a member of the Client Ohio, Process Development organization, this role serves as project manager for Final Drug Product New Process Introductions (NPI) into Client Ohio.

    NPI scope may include the implementation of various drug product formats (e.g.

    vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.

    The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.

    Primary responsibilities include assessment of NPI s for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.

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