GMP MANUFACTURING TECH

Duke Careers • Durham, NC

5d • $23 - $41 • Onsite

About The Position

Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Duke University’s Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has a growth opportunity for a motivated individual to fill a GMP Manufacturing Technician in their Carolina Cord Blood Bank organization.
The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical use. In addition, this individual will be responsible for supporting the daily operation of the CCBB 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 products for hematopoietic cellular transplantation.

Requirements

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

Nice To Haves

• 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.

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 as directed. 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.

Benefits

• Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees