FUJIFILM Cellular Dynamics is a leading developer and supplier of human cells used in drug discovery, toxicity testing, stem cell banking, and cell therapy development. We partner with innovators from around the world to combine biologically relevant human cells with the newest technologies to drive advancements in medicine and healthier living. Our technology can be used to create induced pluripotent stem cells (iPSCs) from anyone and followed by the powerful capability to develop into virtually any cell type in the human body. Our proprietary manufacturing system result in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity, and reproducibility required for drug and cell therapy development

FUJIFILM Cellular Dynamic, Inc in Madison, WI is recruiting for a seasoned operations professional in the role of Associate Director, Therapeutics Manufacturing.   In this critical leadership position you will direct, and lead the manufacturing of FCDI's therapeutic products in compliance with cGMPs.  You will also provide therapeutic manufacturing strategic direction, decision-making, leadership, planning and prioritization, along with the effective and efficient use of resources and organizational structure to meet business goals.    You will be a key influencer in creating and maintaining a culture of quality and compliance,  FCDI aspires to improve the quality of life through our efforts.  In return FCDI will provide development and support to enhance your career in supporting our development and delivery of cutting edge stem cell technology.  Qualified individuals must be inspired to support the development of cell-based therapies.

Essential Job Functions

1. Provide technical and managerial leadership in all areas of GMP manufacturing for FCDI business.
2. Develop and encourage best practices for operational excellence and continuous improvement with all cross functional interfaces - measuring and driving performance of manufacturing based KPIs.
3. Ensure that standards for product quality, manufacturing costs and throughput, equipment and operator performance, employee safety and housekeeping are maintained.
4. Facilitate decision-making, resolve conflicts and build/optimize cross-functional team efforts to assure that all departmental objectives are met.
5. Oversee planning, execution and compliance of the therapeutics manufacturing budget including expense, capital and inventory.
6. Assist in the configuration of distribution center for final product.
7. Develop process plans (User Requirement Specifications) for new buildings (space, equipment, time, process-flows, people, cost).
8. Maintain on-going analysis of key issues, projects, objectives, and provide regular reports that include metrics to summarize the status and trends of key operational parameters.
9. Review needs and provide training opportunities for staff to develop personal job-related skills and to improve operational flexibility in accordance with strategic needs.
10. Work actively on gross margin improvement and COGS reduction.
11. Select, develop, motivate, train and retain a capable staff of GMP manufacturing professionals. 
12. Actively foster an environment of continuous improvement.
13. Ensure fixed assets and facilities are preserved using best maintenance practices.
14. Develop departmental goals that support the strategic goals of FCDI.
15. Ensure compliance with applicable quality management system and cGMP standards and requirements. 
16. Ensure compliance with state and federal environmental and safety regulations.
17. Understand and complies with ethical, legal and regulatory requirements applicable to FCDI.
18. Other job functions as assigned.

• Bachelor’s degree in life sciences or a technical field such as biotechnology or biochemical engineering, or comparable field
• 10 years of progressive operations management experience in a company producing biological products in compliance with cGMPs, with demonstrated achievements and progressive responsibilities.
• Demonstrated proficiency managing a diverse staff, including technical professionals and front-line employees
• Demonstrated ability to share knowledge and to develop and mentor staff
• Ability to work collaboratively with other departments in a cross functional team environment
• Demonstrated proficiency in the development and/or manufacture of cell therapy products  
• Strong organizational and communication skills
• Quality Management Systems expertise (such as cGMPs, TQM, Lean Manufacturing, Six Sigma).
• Proficient in use of ERP systems such as SAP
• Ability to travel – <15%.

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.