Manufacturing Associate (SRA 3) - Dean's Office

Description Under the supervision of the Manufacturing Manager 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.

Salary Range: $66,431.27 - 106,830.32 Annually

Qualifications Required:

• Bachelor of Science or Master of Science or Ph.D. Degree in Biology, Chemistry, or related field.
• Knowledge and practical experience in aseptic technique/tissue culture.
• 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
• 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.
• Excellent record keeping skills and good documentation practices.
• 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 accuracy 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.
• Ability to attend off-site staff meetings, conferences and investigator meetings.
• Exceptional database and computing skills.
• 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.

Preferred:

• A minimum of 2 years of tissue culture experience.
• 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.
• Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.
• Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work.
• 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.