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.

• Maintain sufficient inventory of supplies and reagents for performance of duties.
• Evaluate collected facilities and/or laboratory data and prepare reports as needed with accuracy, completeness, and timeliness, providing recommendations or conclusions as appropriate. Accurately complete and review batch record documentation, all appropriate equipment logs entries, and GMP documentation.
• Write and/or review deviations, equipment problem reports, validations, research plans, reports, SOPs, and batch records as required.
• Maintain equipment calibration schedules and lab space, coordinating with vendors and contractors where required.
• Perform duties in a clean room environment while fully gowned (hood, mask, coverall, boots, gloves, etc.) following GMP guidelines and using aseptic technique. Following standard operating procedures, conduct cellular product manufacturing and under G'X'P (GLP, GTP, GMP, GDP) guidelines.
• Participate in lab inspections and work with inspectors as needed.
• Provide guidance on and participate in cleaning and maintenance of laboratory equipment in good working order.
• Training and supervision of new hires or lower-level manufacturing technicians.
• Coordinate and participate in the preparation of reagents, stains, solutions, chemicals, antibodies, 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 and assist in technology transfer of manufacturing processes from pre-clinical into GMP environment.
• Perform other related duties incidental to the work described herein.

Required Qualifications at this Level

• Education/Training: 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 working with equipment and facilities maintenance. A related master's degree may substitute for two years of required experience.
• 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.

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.