GMP Manufacturing Technician Sr.

About the role

Duke University’s Marcus Center for Cellular Cures has an immediate opening for a Sr. GMP Manufacturing Technician on‑site in their GMP lab located at 2400 Pratt Street, Durham, NC. More information about this lab is available at https://marcuscenter.duke.edu/resources/robertson-gmp-lab.

Responsibilities

• 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.

Requirements

• Education/Training: Work requires a bachelor's degree in science, engineering, or related field.
• Experience: 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.

Skills

• Good communication skills and the ability to work independently as well as part of a 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.

Benefits

Duke offers a competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more. Learn more at: https://hr.duke.edu/benefits/.

Pay

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $98,439.00.