Job: GMP MANUFACTURING TECH II - MARCUS CENTER FOR CELLULAR CURES, Duke University and Health System, Durham, NC
The Marcus Center for Cellular Cures (MC3https://marcuscenter.duke.edu/) has an exciting opportunity as a GMP Manufacturing Technician in their Robertson cGMPLaboratory.The Robertson cGMP Laboratory is a FACT accredited, FDA registered, multi-purpose facility that includes 13 individual rooms and 3 manufacturing rooms, covering 3150 GSF. This facility is dedicated to the manufacturing of biologics and processing of tissues for human clinical use. More information is located at: https://marcuscenter.duke.edu/resources/robertson-gmp-lab/. This position is located at 2400 Pratt Street, Durham N.C. Experience working in a GMP Manufacturing environment highly preferred.
The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for early phase clinical trials as well as support pre-clinical development. In addition, this individual will be responsible for the daily operation of the GMP facility to ensure it is in control and in compliance with applicable regulations. The individual will report to the Scientific/Research Lab Manager of the GMP Facility.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.
- Perform duties as dictated by standard operating procedures (SOPs) for cell manufacturing and under G'X'P (GLP,GTP, GMP) guidelines as directed.- Perform duties in a clean room environment following GMP guidelines.Operate instrumentation as needed for cell manufacturing such as cell seperators (Sepax), cell counters (SysmexXS1000i or equivalent).- Perform cell based assays (such as flow cytometry, colony forming unit assays) and other assays (gram stain,endotoxin) to analyze, quality control and/or release a cellular product. Use aseptic technique to manufacture cell products for clinical trials.- Operate manual and automatic laboratory equipment to count cells; stain cells, wash cells,identify and quantify cell populations including stem cells.- Perform environmental monitoring for the GMP laboratory.- Assist in technology transfer of procedures from pre-clinical into GMP environment.- Write SOPs, and batch records as required. Write validation plans and reports, stability plans and reports and study reports.- Work with Lab manager and quality assurance to ensure the facility is in compliance for governing regulations.- Participate in lab inspections and work with inspectors as needed.- Evaluate collected laboratory data and prepare reports as needed with accuracy, completeness, and timeliness as well as provide recommendations or conclusions as appropriate.- Maintain sufficient inventory of supplies and reagents for performance of duties; clean and maintain laboratory equipment in good working order.- Prepare and qualify reagents, stains, solutions, chemicals, and culture media as appropriate.- Coordinate and participate in the preparation of antibodies, reagents, and solutions necessary for cell processing and testing.-Utilize various laboratory and hospital computer information systems and software- Provide advanced problem solving, troubleshooting, interpretation/consultation, verification of specimen quality, and test results as needed- Use knowledge of laboratory safety and infection control procedures and practices to safely perform required work including standard 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.- Assure remedial action is taken and documented whenever tests systems deviate from established performance specifications. Perform other related duties incidental to the work described herein. Required Skills: Ability to work independently as well as part of team. Good communication skills, interaction in a professional and courteous manner with co-workers, and others.
Work requires a bachelor's degree in botany, biology, zoology, psychology or other directly related scientific field.
Work requires two years of research experience. A related master's degree may offset required years of experience on a 1:1 basis, e.g., a two year master's degree in lieu of two years of experience.OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Duke University 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 essential job 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.