Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Lead Manufacturing Associate 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.

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