FUJIFILM

  • Vice President of Operations

    Job Locations US-WI-Madison
    Posted Date 2 months ago(6/14/2018 8:42 AM)
    Requisition ID
    2018-2715
    Category
    Operations
    Company (Portal Searching)
    FUJIFILM Holdings America Corporation
  • Overview

    Cellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. The Company partners with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. CDI’s technology offers the potential to create induced pluripotent stem cells (iPSCs) from anyone, starting with a standard blood draw, and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system produces billions of cells daily, resulting in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development. 

     

    It is an exciting time to be joining FUJIFILM.  We are an evolving and growing organization each day.  To support this growth we are hiring a Vice President of Operations.  The Vice President of Operations directs FUJIFILM Cellular Dynamics’ development and production of non-regulated products (non-GMP) and cell therapy (GMP) products for a variety of research customers, CDMO/CMO clients, and FCDI collaborators, including the management of all activities related to facilities, process engineering, tech transfer, manufacturing, regulatory compliance, quality systems integration, and supply chain management.  The role manages the deployment and on-going management of a state-of-the-art cleanroom facility to support production of cell therapies under current Good Manufacturing Practices (cGMP) for early-stage human clinical trials.  This includes but is not limited to the integration and deployment of quality system and infrastructure to support commissioning, validation and maintenance of the facility and associated equipment, and for manufacture, testing, and release of clinical products.  In addition, the role will build and manage a robust supply chain – purchasing, demand planning, inventory management, distribution and required functional support for the entire operations.   

    External US

    Essential Functions

     

    1. Direct core operations over all FCDI facilities – ensuring measurable performance standards, consistent with regulatory requirements, aligned with business objectives, and proactive approaches to operational efficiency and performance.
    2. Oversee the startup of the cleanroom facility and associated laboratory space to support cGMP production of cell therapies, process qualification/validation, and Quality Control testing activities
    3. Direct the development and execution of commissioning documentation, Validation Master Plan and validation protocols to support establishment of the facility and associated utilities and equipment.
    4. Integrate and deploy process engineering capabilities across all production platforms – promoting design for manufacturability within product development functions, to also include technology transfer, specifications, robustness, process validation and the refinement and management of materials and vendors.
    5. Build and deploy a robust supply chain management function and capabilities providing controls, visibility, redundant supplier coverage, and predictable utilization, and purchasing efficiency.
    6. Oversee the integration of quality systems to support cGMP manufacturing and testing for cell therapies for pre-clinical animal studies and human clinical trials.
    7. Interface with R&D to transfer cell manufacturing processes to support core non-regulated products and production of iPSC banks, differentiated and genetically modified cell therapies
    8. Oversee manufacturing sciences activities,
    9. Serve as the CMC subject matter expert for interactions with clients and regulatory authorities. Author regulatory filing documents and responses to regulatory questions.
    10. Oversee management of capital and operational budgets to insure efficient and cost-effective management of group activities.
    11. Facilitate and drive on-going change management and process improvement initiatives.
    12. Select, develop, motivate, and retain a team of qualified operations professional.
    13. Provide recommendations in strategic directions for cell manufacturing and cell therapy product development.
    14. Maintain a current knowledge of new products, technologies, and regulatory requirements that are related to FCDI’s development and manufacturing plans

    Required Qualifications:

    • Bachelor’s Degree in Operations Engineering or related field.
    • 15 years of operational leadership experience in biotechnology and a FDA regulated facility, demonstrated achievements and progressive responsibilities.
    • Operational expertise within a CMO and/or CDMO operation.
    • Certification through APICS or similar certifications.
    • Relevant startup management experience with greenfield cGMP facility operation.
    • Metric driven approach to operational management with demonstrated utilization of performance tools supporting communication and process improvement.
    • Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems on complex bio-technology equipment. ​
    • Experience in maintaining regulatory compliance thru audits, validation, change management, risk assessments, qualified drawings, corrective action plans, FMEA, and deviation support.
    • Demonstrated proficiency in fiscal management, risk identification and mitigation, and budget development and communication. 
    • Experience in an FDA regulated facility and equipment maintenance to include clean utilities, such as pure water systems, upstream and/ or downstream equipment.
    • Demonstrated leadership abilities, able to set forth a vision of excellence and reliability in manufacturing and engineering operations; and ability to communicate that vision to all levels of the organization.
    • Knowledge of engineering principles, practices, theories and technologies related to equipment controls, mechanical or electrical/electronic systems and processes
    • Proficiency and understanding of the techniques and procedures of engineering project management as well as OSHA regulations and safe work practices

     

    FUJIFILM  is an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law

     

    To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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