School of Medicine:
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Duke’s Marcus Center for Cellular Cures has an exciting opportunity for a GMP Manufacturing Tech Sr in their GMP lab located at 2400 Pratt Street Durham, NC.
The work schedule for this position is Saturday – Wednesday.
This position is 100% grant-funded.
More information about this lab is located at the link below: https://marcuscenter.duke.edu/resources/robertson-gmp-lab/
OCCUPATIONAL SUMMARY: 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.
WORK PERFORMED: Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Following standard operating procedures, conduct cellular product manufacturing and under G’X’P (GLP, GTP, GMP, GDP) guidelines. Execute and give guidance on cell manufacturing instrumentation operation including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets. Accurately complete and review batch record documentation, all appropriate equipment log entries, and GMP documentation. Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification. 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. Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness, providing recommendations or conclusions as appropriate. Write and review validations, research plans and reports, SOPs, and batch records as required. Maintain equipment calibration schedules and lab space, coordinating with contractors where required Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed. Assure remedial action is taken and documented whenever test systems deviate from established performance specifications. Work with Lab manager and quality assurance colleagues to ensure the facility is in compliance with governing regulations. Participate in lab inspections and work with inspectors as needed. Maintain sufficient inventory of supplies and reagents for performance of duties. Provide guidance on and participate in cleaning and maintenance on laboratory equipment in good working order. Training of new hires or lower level manufacturing technicians. Coordinate and participate in the preparation of reagents, stains, solutions, chemicals, antibodies 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. Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff. Perform other related duties incidental to the work described herein. Required Skills: Good communication skills and the ability to work independently as well as part of team. 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.
Work requires a bachelor's degree in science, engineering, or related field.
Work requires a minimum of two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of required experience.
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