GMP Manufacturing Technician

1w1 week ago

Duke University

Durham, US · Full-time · $44,000 – $80,000

About this role

The Marcus Center for Cellular Cures (MC3) has an exciting growth opportunity for a GMP Manufacturing Technician in their Carolina Cord Blood Bank Lab. This on-site position supports highly complex manufacturing of cellular products for clinical use. The role ensures the CCBB facility remains in control and compliant with regulations.

Perform duties dictated by standard operating procedures (SOPs) for licensed DUCORD product and other hematopoietic cellular products, including bone marrow and peripheral blood stem cells. Employ aseptic technique in biological safety cabinets and operate equipment like cell separators, centrifuges, and LN2 freezers. Accurately complete batch record documentation and equipment log entries.

Join an integral team working together to produce the highest quality clinical products for hematopoietic cellular transplantation. Collaborate with Lab Manager, other CCBB Manufacturing Technicians, and Quality Systems Unit. Thrive in Duke University School of Medicine's inclusive community where interdisciplinary collaboration accelerates scientific discoveries.

Contribute to MC3's vision of a world with access to high-quality cell-based therapies and mission to design, develop, and deliver cellular therapies. Work Tuesday–Friday, 9:00 am–5:30 pm in a world-class academic medical center. Embrace opportunities in a motivated, team-oriented environment.

Requirements

Bachelor's degree in science, engineering, or related field
Laboratory experience in a GMP/regulated environment preferred
Up to two years of laboratory experience preferred
Related master's degree may substitute for two years of experience
Familiarity with cGMP guidelines for clinical manufacturing
Proficiency in aseptic technique and biological safety cabinet use
Ability to accurately document batch records and logs

Responsibilities

Perform duties as dictated by standard operating procedures (SOPs) for manufacturing licensed DUCORD product and other hematopoietic cellular products under cGMP guidelines
Utilize biological safety cabinet and employ aseptic technique
Operate manual and automatic instrumentation including 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
Support daily operation of the CCBB facility to ensure compliance with applicable regulations
Work with Lab Manager, other CCBB Manufacturing Technicians, and Quality Systems Unit