We develop and manufacture fully functioning human cells in industrial quantities to precise specifications. Our proprietary iCell Operating System (iCell O/S) includes true human cells in multiple cell types (iCell products), human induced pluripotent stem cells (iPSCs) and custom iPSCs and iCell products (MyCell products).

Our iCell O/S products provide standardized, easy-to-use, cost-effective access to the human cell, the smallest fully functioning operating unit of human biology. Customers use our iCell O/S products, among other purposes, for drug discovery and screening; to test the safety and efficacy of their small molecule and biologic drug candidates; for stem cell banking; and in researching cellular therapeutics

We are in the market for the newly created role of  Vice President, Operations.  In this hands-on role you will direct FUJIFILM Cellular Dynamics’ development and production of non-regulated products (non-GMP) and cell therapy (cGMP) 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. 

Qualifed candidates will ideally have green-field cGMP start up expereince, establishing operating functionality, systems, processes, and controls in a small molecule environment.  You will be responsible for building and developing a capable team, and facilitating process improvement and change management across all company operations.   

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.       Serve as the CMC subject matter expert for interactions with clients and regulatory authorities.  Author regulatory filing documents and responses to regulatory questions.

9.       Oversee management of capital and operational budgets to insure efficient and cost-effective management of group activities.

10.    Facilitate and drive on-going change management and process improvement initiatives.

11.    Select, develop, motivate, and retain a team of qualified operations professional.

12.    Provide recommendations in strategic directions for cell manufacturing and cell therapy product development. 

13.    Maintain a current knowledge of new products, technologies, and regulatory requirements that are related to FCDI’s development and manufacturing plans.

• Bachelor’s Degree in operations engineering or related field.
• 15 years of operational leadership experience in biotechnology and in a FDA regulated facility, with 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 through 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 Cellular Dynamics, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with a disability. All qualified applicants will not be discriminated against on the basis of a disability.