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 2,600 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.

Duke University’s Marcus Center for Cellular Cures (MC3) has an immediate opening for a Manufacturing Technician in our GMP Manufacturing Laboratory.

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

More information is available at the following link: https://marcuscenter.duke.edu/

OCCUPATIONAL SUMMARY:

The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for clinical trials and commercial operations. In addition, this individual will be responsible for supporting the daily operation of the GMP 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 material for novel cellular therapies.

WORK PERFORMED:

Perform duties as dictated by standard operating procedures (SOPs) for cellular product manufacturing and under G’X’P (GLP, GTP, GMP, GDP) guidelines as directed.  Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Perform cell culture of a variety of cell and tissue types using various vessels and media formulations to specifications outlined in batch records. Operate instrumentation needed for cell manufacturing including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets. Accurately complete batch record documentation, all appropriate equipment log entries, and GMP documentation. Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.  

Work with Lab Manager, other GMP Manufacturing Technicians, and Quality Assurance 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

Prepare and qualify reagents, stains, solutions, chemicals, and culture media as appropriate. Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including universal precautions and hazardous chemical handling.

Assist in technology transfer of manufacturing processes from pre-clinical into GMP environment.

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 GMP team and other departmental staff.

Ability to read and understand Standard Operating Procedures.

Preferred Skills:

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.

Perform other related duties incidental to the work described herein.

Required Qualifications at this Level

Education/Training

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

Experience

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.

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.