• Sr. Manager, Process Engineering

    Job ID
    11016
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Manufacturing
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The Cell Therapy Production Facility (CPF) is a department within the Therapeutic Products Program division that manufactures T-cell and stem cell therapeutic products for clinical trials.  Within the CPF, there is a functional unit that supports clinical manufacturing by creating and/or revising manufacturing production batch records and SOPs. This position will oversee Process Engineering Specialists and Technical Writers in the development and creation of these GMP documents. They will also be responsible for development, facilitation and oversight of internal process and technology transfer from scientific and Process Development staff to Manufacturing personnel.

    Responsibilities

    The CPF Process Engineering Sr. Manager will primarily focus on the oversight of MFG batch record development, creation and revision, with appropriate support of standard operating procedures, to ensure a continued state of regulatory compliance and continuity of clinical manufacturing operations.

     

    • Track, schedule and ensure on-time completion of required GMP clinical MFG batch records and SOP documentation.
    • Manage a group of Process Engineers and Technical Writers in the creation and revision of MFG operations documentation used in the execution of operations.
    • Interface and collaborate with Principal Investigators, Process Development, and Clinical staff in support of internal process transfer to ensure appropriate manufacturability and scalability of processes.
    • Lead and/or facilitate cross functional teams in various projects and initiatives designed to improve process transfer and operations documentation deliverables.
    • Identify, and articulate to stakeholders, Continuous Process Improvement opportunities, and assist in trouble shooting and problem solving to simplify and improve efficiencies within MFG.
    • Assist in the development, and utilize tools, to collect and process feedback on use of GMP documentation.
    • Assist in the coordination of process development activities with adherence to clinical project milestones and timelines
    • Within GMP systems, support and organize technology transfer for new MFG equipment selection, procurement and onboarding.
    • Support execution of development and engineering runs in preparation for clinical operations.

    Qualifications

    Required:

    • BS/MS in a biological science with 5+ years (4+ years with MS) or relevant background in biologics and/or cellular therapeutics operations. Relevant experience in lieu of degree acceptable.
    • Experience working in a regulated (GMP) environment, including a thorough understanding of GMP record keeping and documentation practices. 
    • Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
    • Strong verbal and written communication skills with demonstrated ability as a technical author of GMP documentation.
    • Experience with management and supervision of personnel.
    • Experience working as a customer service provider.

     

    Preferred:

    • Strong administrative and logistics skills required to track a large variety and volume of tasks simultaneously.
    • Strong troubleshooting and problem solving skills. 
    • Experience working in cellular therapeutics and/or biologics manufacturing environment.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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