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Duke University Job Description: |
Job Title: GMP MANUFACTURING TECH |
Job Code: 3016 |
FLSA: |
Job Level: 51 |
Revised Date: 04/01/2020 |
Job Family: JF 05 |
The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. In addition, this individual will be responsible for supporting the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual filling this position will be an integral member of a team working together to produce the highest quality clinical material for novel cellular therapies.
Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines as directed. Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Perform cell culture of a variety of cell and tissue types using various vessels and media formulations to specifications outlined in batch records. Operate instrumentation needed for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets. Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation. Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
Work with Lab Manager, other GMP Manufacturing Technicians, and Quality Assurance to ensure the facility is in compliance for governing regulations. Maintain orderly lab spaces. Participate in lab inspections and work with inspectors as needed. Record and inform of any insufficient inventory of supplies and reagents; clean and maintain laboratory equipment in good working order
Prepare and qualify reagents, stains, solutions, chemicals, and culture media as appropriate. Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
Assist in technology transfer of manufacturing processes from pre- clinical into GMP environment.
Use dexterity, knowledge, and ability to complete assigned laboratory tasks and skills, with attention to detail and compliance with all appropriate laboratory regulatory and safety requirements.
Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
Ability to read and understand Standard Operating Procedures.
| Education/Training: | Work generally requires a bachelor's degree in science, engineering, or related field. |
| Experience: | None required above education/training requirement. Prefer up to two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of experience. |
| Skills: | Good communication skills and the ability to work independently as well as part of team. Communicate and interact in a professional and courteous manner with co-workers, and others. Must be team oriented and able to work in a highly collaborative work environment to complete complex tasks. Must be able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts. The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job related tasks other than those specifically presented in this description. |
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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