GMP Manufacturing Tech

About the role

The Marcus Center for Cellular Cures (MC3) at Duke University’s Carolina Cord Blood Bank is seeking a GMP Manufacturing Technician to support the production of cellular products for clinical use under cGMP guidelines.

Responsibilities

• Perform duties as dictated by standard operating procedures (SOPs) for the manufacturing of licensed DUCORD product and other hematopoietic cellular products, including but not limited to bone marrow and peripheral blood stem cells for clinical use under cGMP guidelines.
• Utilize a biological safety cabinet and employ aseptic technique. Operate manual and automatic instrumentation needed for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and LN2 freezers.
• Accurately complete batch record documentation, and all appropriate equipment log entries.
• Participate in Proficiency Testing surveys as applicable.
• Maintain responsibility and donor confidentiality.
• Work with Lab Manager, other CCBB Manufacturing Technicians, and Quality Systems Unit 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.
• Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.
• 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 CCBB team and other departmental staff. Attend routine laboratory and departmental meetings.
• Ability to read and understand Standard Operating Procedures. Complete assigned training and required competency and proficiency assessments. Complete required continuing education hours.
• Perform other related duties incidental to the work described herein.

Qualifications

• Work generally requires a bachelor's degree in science, engineering, or related field.
• Preferred Qualifications: 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.

Preferred 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.

Benefits

Duke University 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. Duke University is committed to creating a diverse and inclusive workplace.

Pay

The anticipated pay range for this position is USD $22.61 to USD $40.70 annually. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Physical Job Functions

• Essential physical job functions include sitting, standing, walking, lifting, reaching, grasping, and using fine motor skills.