GMP MANUFACTURING TECH 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.

Duke’s Marcus Center for Cellular Cures has immediate openings for a Sr. GMP Manufacturing Technician in their GMP lab located at 2400 Pratt Street Durham, NC.  

 More information about this lab is located at the link below:

 https://marcuscenter.duke.edu/resources/robertson-gmp-lab

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 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 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.

Execute and give guidance on cell manufacturing instrumentation operation including but not limited to cell separators, cell counters, centrifuges, incubators, pipettes, and Biological Safety Cabinets.  Accurately complete and review batch record documentation, all appropriate equipment log entries, and GMP documentation. Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification. 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.

Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness, providing recommendations or conclusions as appropriate.

Write and review validations, research plans and reports, SOPs, and batch records as required.

Maintain equipment calibration schedules and lab space, coordinating with contractors where required

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.

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.

Maintain sufficient inventory of supplies and reagents for performance of duties.  Provide guidance on and participate in cleaning and maintenance of laboratory equipment in good working order.

Training 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. 

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

Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.

Perform other related duties incidental to the work described herein.

Required Skills:

Good communication skills and the ability to work independently as well as part of a team. 

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.

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.