GMP Research Associate

Job description

Position Type:

Permanent Staff (EHRA NF)

Lineberger Compr Cancer Center-426801

GMP Research Associate

EHRA Non-Faculty

Research Professionals

Dependent on Qualifications and Experience

Full-Time Permanent

40

NF0004572

01004252

11/12/2020

12/04/2020

No

11/02/2020

The person in this position will be responsible for the production of human cellular therapy products intended for administration to patients enrolled in clinical trials following all regulatory requirements to ensure compliance with federal and state statutes. Cell products may be from patients with infectious diseases including HIV. Production will be guided by specific procedures and accurately documented in completely filled out manufacturing records. Sampling and analysis for quality control purposes, product and sample inventory storage, transportation (position requires that the employee use their personal vehicle to transport samples from facility on Hwy 54 to UNC campus) and shipping of product/samples, materials tracking and management, and data collection/reporting are additional functions in this position. Person will take lead in developing SOPs and collaborate with investigators in translation of bench-scale techniques to large-scale production. Person will work with team members to assure compliance with regulatory requirements.

Post-Bachelor’s degree in biological or chemical science (or equivalent) or a Bachelor’s and three years of relevant experience.

Knowledge and experience in aseptic technique and manual mammalian cell culture. Willing to work in clean room environment with potentially infectious materials. Demonstrated and extensive skills in the operation and troubleshooting of complex laboratory machines (e.g. automated immunomagnetic separation devices). Experience in cellular therapy production. Proficiency with MS Office. Valid NC driver’s license.

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.

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