GMP Manufacturing Technician Sr.

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 a 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-Saturday – 8:30 am – 5:00 pm.  

The Marcus Center’s mission and values are listed below:

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

Coordinate and participate in a variety of clerical and laboratory duties of a complex and technical nature in support of the receipt, processing, purification, analysis, and cryopreservation of hematopoietic cells obtained from umbilical cord blood, for hematopoietic stem cell transplantation.

The individual filling this position will be an integral member of a team of physicians, nurses, collection specialists, and other professionals providing cord blood collection and processing services for the Carolinas Cord Blood Bank.

Work Performed

Perform a variety of complex, technical duties involved in the manufacture of licensed DUCORD product from collected umbilical cord blood.  Utilize a biological safety cabinet and employ aseptic techniques while conducting and participating in the processing, and cryopreservation of hematopoietic stem cells obtained from umbilical cord blood.  

Operate manual and automatic laboratory equipment used to count cells; stain cells; separate cells; wash cells; separate plasma, red cells, buffy coats, mononuclear cell populations and stem cells; and cryopreserve cells according to standard operating procedures for the Carolinas Cord Blood Bank. Perform ABO/Rh blood typing of cord blood units. Unload BacT/Alert and print sterility reports. Confirm units for removal from inventory post exclusion from banking.  Assist with removal of segments for confirmatory typing and shipping of prepared samples.  Print IDM results.  Perform cleaning, maintenance and quality control on equipment and reagents.

Receive and prepare cord blood unit and associated documents from local and remote collection sites; execute administrative functions to prepare cord blood units for processing. Receive and prepare maternal samples and associated documents from local and remote collection sites; prepare maternal samples for shipment to the testing facility for infectious disease testing.  Unload and return cord blood shipping containers to remote collection sites.

Coordinate and participate in the preparation of culture media, chemicals, antibodies, pharmaceuticals, reagents, and solutions necessary for cell processing and cryopreservation.

Complete laboratory data forms and enter them into the electronic database for the bank. Prepare cord blood unit working and confidential files for administrative, technical, and medical review. Continually review and file paperwork and test results into the working file, ensuring that the file is completed and finished according to standard operating procedures.  In collaboration with senior lab personnel, evaluate collected laboratory data as outlined in the Carolinas Cord Blood Bank standard operating procedures.

Bring to the attention of the laboratory management staff concerns regarding individual cord blood units or indications that a local or remote site is not incompliance with established Carolinas Cord Blood Bank standard operating procedures.

Attend routine laboratory meetings and other meetings related to laboratory functions; stay abreast of pertinent information and any changes to standard operating procedures. Complete assigned Master Control training and complete required competency and proficiency assessments. Complete required continuing education hours.

Orient new employees to the Carolinas Cord Blood Bank.  Coordinate/trigger training tasks in Master Control.  Train new employees on standard operating procedures and oversee the successful completion of employee initial training performing checklists.

Collaborate with a supervisor to oversee and perform any of the following; supply and inventory management, equipment inventory and preventative maintenance, data logger download and inventory management, and/or offsite file management.

Under the supervision of senior lab personnel, assist in development of standardoperatingprocedures for the Carolinas Cord Blood Bank.  Participate in the development of new medical and laboratory procedures and techniques as they relate to public cord blood banking.  Assist with analytical, equipment, and process validation procedures.

Other duties integral to cord blood processing and banking.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 Preferred Skills:

Problem Solving Skills

Attention to detail.

Excellent interpersonal skills.

Excellent communication skills, both written and oral.

Excellent organizational skills.

Experience with sterile techniques/methods is desirable.

Data entry skills.

Minimum Qualifications
Education

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

Experience

Work requires a minimum of two years of laboratory experience, preferably in a GMP/regulated environment. A related master's degree may substitute for two years of required 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.

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.