Lead Manufacturing Scientist, CAB - Dean's Office

Under the
supervision of the Manufacturing Manager of the Center for Advanced
Biotherapies (CAB), the CAB Lead Manufacturing Scientist is responsible for the
manufacturing of human gene and cell therapy products under Good Manufacturing
Practices (GMP), quality control testing of these products to ensure that the
products meet the required quality, oversee other manufacturing associates and
overall management of all projects. The purpose of the CAB is to manufacture
clinical grade gene and cellular therapy products for novel patient treatments
in clinical trials, and to perform scholarly research and development when
appropriate. These objectives are to be met within the limits of resources
available with an emphasis on cost effectiveness and innovation.

The Lead
Manufacturing Scientist must have advanced tissue culture expertise, preferably
including human cell line and stem cell culture. This position requires
experience with GMP-grade culture and formulation of various human cell types,
including peripheral blood mononuclear cells (PBMCs), T cells, dendritic cells,
mesenchymal stromal cells, human embryonic stem cells, and induced pluripotent
stem cells. In addition, the candidate must possess strong project and
personnel management skills and have experience conducting and managing quality
control testing.

Annual Salary
Range: $90,720.00 - $194,040.00

Required:

• Bachelor of
  Science or Master of Science or Ph.D. Degree in Biology, Chemistry, or related
  field and a minimum of 2 years of manufacturing experience in GMP setting.
• Knowledge and
  practical experience in aseptic technique/tissue culture.
• Understanding of GMP requirements and regulations. Previous experience
  directly involved with federal regulations regarding GLP and GMP.
• Knowledge of Standard Operating Procedures and Quality Control
  requirements in a GMP laboratory setting.
• Work independently, with emphasis on the ability to closely follow SOPs.
• Ability to wear protective clothing for extended periods of time
  including: gowns, coveralls, gloves, masks, face shields, goggles, sleeves and
  head covers.
• Ability to work
  flexible hours, various hours on short notice (including covering staff
  shortages and holiday shifts); determine workload priorities for completion of
  job assignments in a timely manner to meet critical deadlines
• Ability to
  serve as a resource for complex procedure or equipment troubleshooting in areas
  of expertise, and/or solicits same as necessary in areas where expertise is
  deficient.
• Work under
  regular exposure to zoonotic diseases, anesthetic agents, and cleaning
  chemicals.
• Strong
  interpersonal communication skills to effectively and diplomatically interact
  with physicians, staff, administration & sponsors.
• Experience
  managing complex projects is required as well
• Advanced
  knowledge of cell culture, cell line development, bioreactor operation and
  scale-up, centrifugation and ultracentrifugation, tangential flow and normal
  flow filtration
• Expert in flow
  cytometry, protein, mRNA, DNA characterization
• Excellent
  record keeping skills and good documentation practices.
• Demonstrated ability to work independently and collaboratively with
  multiple departments while utilizing innovation to elicit compliance.
• Demonstrated ability to carry out analytical tasks, to identify and define
  issues and alternatives, to resolve problems, and to draw logical conclusions.
• Demonstrated skill in gathering pertinent data, preparing narrative
  reports, statistical reports, charts, graphs, and tables.
• Demonstrated skill in reviewing documents, data and material compiled by
  others for completeness and accruacy to ensure that incorrect/incomplete data
  is corrected.
• Ability to deal with and maintain confidential and sensitive information
  with discretion.
• Demonstrated skill in good decision making and taking appropriate action
  in situations where no established criteria exists or where answers to problems
  are not readily available.
• Ability to work on a diverse variety of projects simultaneously, organize
  multiple projects for efficiency and cost-effectiveness.
• Demonstrated skill in prioritizing workflow to meet deadlines, often under
  pressure of conflicting demands, while maintaining accuracy and effectiveness
  of work.
• Ability to attend off-site staff meetings, conferences and investigator
  meetings.
• Ability to write concise and accurate administrative reports, policies,
  procedures, and correspondence.
• Working knowledge of some medical and scientific terminology for protocol
  abstracting and conversation with research personnel.
• Demonstrated skill in records management. Skill in establishing and maintaining complex filing systems.
• Demonstrated skills with personal computers, spreadsheets, databases and
  word processing applications for the maintenance of records, analysis of data,
  and the preparation of reports.