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

We are in the market for qualified candidates for the newly created position of Director, Process and Analytical Development    In this critical, and hands-on role you'll direct process and analytical development within FCDI R&D for Discovery Research and Therapeutic programs.  You will be developing and leading a diverse team of scientists and engineers responsible for analytical development, process development, technical optimization, bioprocess scale up, and analytical tech transfer.  The role has budgetary responsibility for directly managed projects and ensures functional support is available for project teams on a matrixed basis as needed.  This high visibility role will communicate effectively with senior management and project leadership.  You will also monitor emerging process and analytical technologies and advances the companies capabilities to meet business needs, and facilitate implementation of standardized processes across FCDI projects.

Essential Job Functions

1. Provide technical guidance and resources to FCDI product development team to ensure the on-time development and qualification of high-quality assays and procedures, including tech transfer to FCDI manufacturing and quality control.
2.  Oversee development and implementation of standard practices for analytical and process development projects.
3. Manage staff workloads and ensure adequate skilled staffing available to meet all FCDI development project requirements.
4. Oversee ongoing implementation and training methodologies to drive continuous improvement in process and analytical development. 
5.  Provide consulting and expertise to the overall R&D organization in Design of Experiments and other development best practices.
6. Select, develop, motivate, train and retain a professional staff of analytical and process developers.
7. Lead, manage, and ensure desired outcomes for assigned projects.
8. Other job functions as assigned.

• Ph.D. in biomedical, bioprocess, or chemical engineering or biological sciences.
• 10 years of relevant experience in process and/or assay development in a Biotech or Pharma setting to include team and functional management, to also include project leadership roles.  Experience in cell therapy preferred.
• Demonstrated proficiency in managing and developing technical staff
• Demonstrated capability to develop deep knowledge of the relevant biological science
• Functional proficiency with assay and/or process qualification and validation studies
• Demonstrated proficiency in communicating effectively with and influencing all levels of an organization.
• Demonstrated leadership working in a complex corporate structure and an ability to influence across departmental boundaries to affect positive change
• Proven track record of attention to detail, ability to create and maintain organized and clear project documents (timelines, requirements, issues lists, etc)
• High level of intellectual curiosity and is comfortable with ambiguity
• Proven ability to be flexible and willing to accept new responsibilities as needed.
• Able to work at computer for extended periods of time.
• Travel up to 10%

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.