GMP Manufacturing Technician - Marcus Center for Cellular Cures (CCBB)

School of Medicine

Established in 1930, 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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

The Marcus Center for Cellular Cures (MC3) (https://marcuscenter.duke.edu/) has an exciting growth opportunity for a motivated individual to fill a GMP Manufacturing Technician in their Carolina Cord Blood Bank Lab.

Work Schedule:  Tuesday – Friday 10:30 am – 7:00 pm and Saturday: 9:30 – 6:00 pm

Our Vision: To live in a world where every person has access to high quality and effective cell based therapies

Our Mission: Together we design, develop and deliver the highest quality cellular therapies to improve health

OCCUPATIONAL SUMMARY:

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.

WORK PERFORMED:
 

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 tithe work described herein.

Preferred Skills
Good communication skills and the ability to work independently as well as part of a 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 the ability to quickly learn new skills and concepts.

Minimum Qualifications

Education

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

Experience

None required above education/training requirement. Prefer up to two experience. years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of experience.

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

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Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.