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GMP CELL THERAPY TECH - MARCUS CENTER for CELLULAR CURES

at Duke University Hospital

Posted: 7/30/2019
Job Reference #: 1355146
Keywords: patient

Job Description

Auto req ID
110601BR

Duke Entity
MEDICAL CENTER

Job Code
951 RESEARCH TECHNICIAN II

Job Description
The Marcus Center for Cellular Cures has an exciting opportunity for a GMP Cell Manufacturing Technician located in The Robertson cGMP Laboratory Durham, N.C. More information about the Marcus Center and the Robertson cGMPlaboratory is located at thefollowing link:(s):

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

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 will report to a GMP Manufacturing Supervisor. 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 limitedto 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.
-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.
-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.
-Perform other related duties incidental to the work described herein.

SKILLS:

-Ability to work and maintain strong relationships with the department manager, members of the GMP team and other departmental staff.
-Good communication skills and the ability to work independently as well as part of a team.
-Attention to detail
-Ability to read and understand Standard Operating Procedures.

Location
Durham

Requisition Number
401564635

Position Title
GMP CELL THERAPY TECH - MARCUS CENTER for CELLULAR CURES

Shift
First/Day

Job Family Level
08

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Department Name
Marcus Center for Cellular Cures (MC3)

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, 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.



Education

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

Experience

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