Lead Manufacturing Scientist - Dean's Office (HGCTF)

Under the supervision of the Manufacturing Manager of the
Human Gene and Cell Therapy Facility (HGCTF), the HGCTF 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, supervise other
manufacturing associates and overall management of all projects. The purpose of
the HGCTF 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 ideal candidate must have excellent tissue culture
skills (human cell line and stem cell culture preferred), be trained in GMP
grade culture and formulation of various human cell types including peripheral
blood mononuclear cells, T-cells, dendritic cells, multi potent stem cells such
as mesenchymal stromal cells, pluripotent stem cells, such as human embryonic
stem cells and induced pluripotent stem cells, project and personnel management
skills and experience in quality control tests.

Annual Salary Range: $86,400 - $184,800

All Required:

• Bachelor of Science or Master
  of Science or Ph.D. Degree in Biology, Chemistry, or related field, or
  equivalent experienceand 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.
• Strong interpersonal
  communication skills to effectively and diplomatically interact with
  physicians, staff, administration & sponsors.
• 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
• Demonstrated skill in records
  management. Skill in establishing and maintaining complex filing systems