Sr. GMP Manufacturing Technician - Marcus Center for Cellular Cures

This Position is Grant Funded

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.

The Marcus Center for Cellular Cures (MC3) https://marcuscenter.duke.edu/ has an exciting growth opportunity for motivated individual to fill a Sr. GMP Manufacturing Technician in their Carolina Cord Blood Bank Lab. The position is located at 2400 Pratt Street, Durham, N.C.

Work hours for this position are primarily Tuesday-Friday 10:30 am – 7:00 pm and Saturday 8:30 am – 5:00 pm.

MC3 Vision: To live in a world where every person has access to high quality and effective cell based therapies

MC3 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. Execute and give guidance on cell manufacturing instrumentation operation 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.

Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness, providing recommendations or conclusions as appropriate. Write and execute validation protocols and SOPs as required.

Maintain equipment calibration schedules, coordinating with contractors where required. Provide guidance on and participate in cleaning and maintenance on laboratory equipment in good working order. Maintain sufficient inventory of supplies and reagents for performance of duties.

Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed. Assure remedial action is taken and documented whenever test systems deviate from established performance specifications through out of specification and deviation event management processes.

Work with Lab manager and quality assurance colleagues to ensure the facility is in compliance with governing regulations.

Participate in lab inspections and work with inspectors as needed.

Orient, train and mentor new hires or lower level manufacturing technicians.

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.

Preferred Qualifications:

· Problem-solving Skills

· Attention to detail

· Excellent interpersonal skills

· Excellent communication skills, both written and oral

· Excellent organizational skills

· Data entry skills

· Experience with sterile techniques/methods is desirable

· Familiarity with Good Manufacturing Practices (GMP) is highly desirable

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.

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.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.