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    Production Manager - Indiana, United States - RayzeBio

    RayzeBio
    RayzeBio Indiana, United States

    2 weeks ago

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    Description

    Job Title: Manager, Production

    Location: Indianapolis

    Background

    RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC) and breast cancer. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

    Summary

    The Director of Production will be responsible for oversight, development, and leadership of drug product and isotope production teams. The Director of Production will set vision and drive a culture of compliance and teamwork in a GMP radiopharmaceutical environment.The Director of Production will work with department managers to establish KPI's, training programs, and setting of clearly defined roles and responsibilities for department personnel.The Director of Production will work cross functionally to meet corporate objectives and implement systems related to the commercialization of RayzeBio's programs. The Director of Production will establish and manage teams of high performers to ensure a consistent and timely global supply chain is achieved.

    Job Responsibilities

    Essential duties and responsibilities include the following. Other duties may be assigned.

    • Provide in-plant leadership and guidance for production personnel and ensure GMP compliance for clinical and commercial drug product and/or isotope production.
    • Manage external cleaning vendors and or other support vendors related to GMP cleanroom operations.
    • Support the development and implementation of a robust employee training program.
    • Draft GMP documentation including but not limited to Batch Records, SOP's, forms, Deviations, CAPA's, Change Controls and reports.
    • Support investigations and implement preventative action plans.
    • Support the building of a production team including drafting job descriptions, interviewing and hiring of personnel.
    • Conduct performance reviews and lead employee development programs.
    • Establish and manage production department KPI's related to performance and throughput of GMP radiopharmaceutical operations.
    • Support validation activities related to hot cells and production cleanrooms.
    • Ensure compliance with NRC, EH&S and US/EU GMP regulatory guidelines as required.

    Education and Experience

    • BS or MS in scientific related field or equivalent work experience
    • 7+ years of experience in Radiopharmaceutical or injectable GMP manufacturing environment.

    Skills and Qualification

    • Highly motivated and organized professional with strong interpersonal and communication skills.
    • Proven experience building and managing teams in a GMP environment.
    • Excellent professional ethics, integrity, and ability to maintain confidential information.
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