Manufacturing Associate

Under the supervision of the Director of the Human Gene and Cell Therapy Facility (HGCTF), the HGCTF Manufacturing Associate (SRA) is responsible for the manufacturing of human gene and cell therapy products under Good Manufacturing Practices (GMP) and quality control testing of these products to ensure that the products meet the required quality per pre-established specifications. 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. In this role, you must have excellent tissue culture skills (human cell line and stem cell culture preferred) in order to 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. Experience in quality control tests and assays such as endotoxin assay and mycoplasma testing is preferred. Monthly Salary Range: $5,374.70 - $8,643.23

Required: * Bachelor of Science or Master of Science or Ph.D. Degree in Biology, Chemistry, or related field and/or a minimum of 2 years of tissue culture experience * Knowledge and practical experience in aseptic technique/tissue culture * Understanding of GMP requirements and regulations. Previous experience directly involved with federal regulations regarding GLP or GMP * Knowledge of Standard Operating Procedures and Quality Control requirements in a GMP laboratory setting * 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, weekends and holidays); determine work load priorities for completion of job assignments in a timely manner to meet critical deadlines * 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 * Excellent record keeping skills and good documentation practices * Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines * Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions * Excellent English-writing skills to compose, proofread correspondence, and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation. * Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel. * Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of records, analysis of data, and the preparation of reports.