GMP Manufacturing Technician

1w1 week ago

Duke University

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

About this role

Duke University School of Medicine, ranked sixth nationally, is a world-class academic medical center. The Marcus Center for Cellular Cures has an exciting growth opportunity for a GMP Manufacturing Technician in the Carolina Cord Blood Bank Lab. This on-site role supports producing cellular products for clinical transplantation.

Perform highly complex manufacturing of licensed DUCORD product and hematopoietic cellular products under cGMP guidelines as dictated by SOPs. Employ aseptic technique in biological safety cabinets and operate cell separators, centrifuges, incubators, pipettes, and LN2 freezers. Accurately complete batch records and equipment logs.

Work with Lab Manager, CCBB Manufacturing Technicians, and Quality Systems Unit to ensure facility control and regulatory compliance. Participate in Proficiency Testing surveys and maintain donor confidentiality. Function as an integral team member in a collaborative environment.

Join an inclusive community where interdisciplinary collaboration accelerates scientific discoveries to improve global health. Align with the vision of accessible high-quality cell therapies and mission to deliver superior cellular products. Embrace opportunities in GMP manufacturing at Duke Health.

Requirements

Bachelor's degree in science, engineering, or related field
Laboratory experience preferred, especially in GMP/regulated environment
Related master's degree may substitute for two years of experience
Knowledge of cGMP guidelines for clinical manufacturing
Proficiency in aseptic techniques and sterile processing
Familiarity with cell processing equipment and instrumentation
Attention to detail for documentation and compliance

Responsibilities

Perform duties per 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 equipment log entries
Participate in Proficiency Testing surveys as applicable
Maintain donor confidentiality
Support daily operation of CCBB facility to ensure regulatory compliance