Sr. Group Leader - Parkinson's Disease Cell Therapy Program - (#314)

  • 525 Science Dr, Madison, WI 53711, USA
  • Full-time

Company Description

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

Job Description

FUJIFILM Cellular Dynamics, Inc. in Madison, WI is recruiting for a Senior Group Leader, Parkinson’s Disease Cell Therapy.  Qualified individuals will be inspired to support the development of therapeutics to support research endeavors. We aspire to improve the quality of life through our efforts. In return we provide development and support to enhance your career in cutting edge iPSC technology. 

In this newly created role you'll manage and develop the Parkinson’s Disease Cell Therapy group with a focus on rapid advancement of products into clinical phase.  Formulate and execute experimental plans to achieve project goals consistent with project timelines to include interpretation of pre-clinical efficacy and safety experiments, effectively communicating experimental results to the research team.  Translate the company’s R&D strategy and translates it into achievable directions and actions for the project team, while collaborating with company managers and other project stakeholders to communicate ideas and progress, working closely with FCDI partners to achieve project goals.  Write protocols, technical reports, Standard Operating Procedures (SOPs) and develops appropriate documentation for processes, to include participation in the technology transfer of processes to the Manufacturing group.

Essential Job Functions

  1. Manage all R&D activities of the cell therapy program to develop iPSC-derived mid-brain dopamine neuron progenitor cells for treatment of Parkinson’s Disease.
  2. Collaborate and communication program status, initiatives, roadblocks and plans with Senior Management to achieve project and organizational objectives.
  3. Act as a liaison with all essential internal functional groups and external collaborators, partners, consultants, CROs, and clinicians.
  4. Write and assemble regulatory documentation in preparation for clinical trials
  5.  Oversee technology transfer to manufacturing resources and partners, implementing process improvements as required.
  6. In collaboration with project management office - manage and communicate project timelines and budget performance to project stakeholders.
  7. Select, develop, train and retain capable staff of research and development professionals to ensure all aspects of the program objectives and timelines are achieved.
  8. Test and implement process improvements, including scale-up technologies.
  9. Evaluate platform technologies and suggest potential technologies for in-licensing or partnership.
  10. Oversee development work on cell therapy pipeline candidates.
  11. Serve as a subject matter expert related to therapies and strategies to treat neuro-degeneration.
  12. Other job functions as assigned.

 

 

Qualifications

  • PhD in biology, molecular biology, biochemistry, biomedical engineering, or related field, or Master’s in comparable field plus 3 years of relevant experience. 
  • 6 years of additional and relevant experience in stem cell biology and neuro-biology, with demonstrated achievements and progressive responsibilities, to include 2 years of project or program leadership/management achieving timelines and budget targets, ideally within a cell therapy environment
  • Expertise in cell culture, purification and analytical strategies, equipment, and processes
  • Demonstrated track record in successfully developing and employing in vitro/in vivo models
  • Demonstrated leadership capabilities to include team development, managing through adversity, effective communication across all levels of stakeholders to include external parties, all with a strategic outlook and ability to defend research positions while achieving program objectives
  • Demonstrated proficiency in managing multiple projects, and changing priorities meet timelines and budgets
  • Overnight travel – 10%
  • Able to work at computer for extended periods of time

Additional Information

 

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.