GMP Manufacturing Tech

Duke Careers•Durham, NC

52d•$23 - $41•Onsite

About The Position

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 2,500 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.Be You. 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. More information is located at the following link: https://marcuscenter.duke.edu/about-us/ 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. Join our award-winning team as identified by Forbes magazine as America’s Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's 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. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $22.61 to USD $40.70. 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. Your total compensation goes beyond the dollars on your paycheck. 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. Learn more at: https://hr.duke.edu/benefits/ Equal Opportunity Employer: Duke is an 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, (including pregnancy and pregnancy related conditions), sexual orientation, or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

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

None required above education/training requirement.
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.