Description

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.

Annual Salary Range: $64,496.38 - $103,718.76

Qualifications

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

• 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 workload 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

• Teamwork skills as well as the ability to prioritize and demonstrate critical thinking.

• Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.

• Excellent English-writing skills to compose, proofread correspondence, and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation.

• Demonstrated skills with personal computers, spreadsheets, databases, and word processing applications for the maintenance of records, analysis of data, and the preparation of reports.

• Demonstrated skill in utilizing programs such as Word, Excel, and other database software.

       

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