RESEARCH TECHNICIAN II - GMP FACILITY

Location
Durham, NC
Posted
Oct 03, 2017
Institution Type
Four-Year Institution

diversity employer



RESEARCH TECHNICIAN II - GMP FACILITY
CT2-CCBB

Occupational Summary

The incumbent in this position is responsible for highly complex and specialized manufacturing of cellular products for early phase clinical trials. 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.

Work Performed

  • 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 separators (Sepax), cell counters (Sysmex XS1000i 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 Work with Lab Manager, Lab Research Analysts and Quality Assurance to ensure the facility is in compliance for governing regulations.
  • Participate in lab inspections and work with inspectors as needed
  • 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.
  • Provide quality control testing, quality assurance data, safety and infection control practices in compliance with internal and external regulations.
  • Maintain responsibility and confidentiality for patient identification, specimen labeling and specimen verification.
  • Coordinate and participate in the preparation of antibodies, reagents, and solutions necessary for cell processing and testing.
  • 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.
  • Ensure that patient testing results are not reported until corrective action has been taken and the test system is functioning properly

Perform other related duties incidental to the work described herein.

Requisition Number
401277977

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
951 RESEARCH TECHNICIAN II

Job Family Level
08

Exempt/Non-Exempt
Non-exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status. 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.

Education

Work requires a bachelor's degree in botany, biology, zoology or other science related scientific field.

Experience

None required above education/training requirement. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Auto req ID

90934BR

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.

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.

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