Clinical Lab Specialist
About The Position
UVA School of Medicine is seeking a Clinical Lab Specialist to manufacture clinical cGMP products and provide technical laboratory support through immune testing used for product release. The role operates under the supervision of the cGMP supervisor or director and supports clinical manufacturing operations in a cGMP environment by maintaining equipment functionality, implementing SOPs, ensuring operational compliance, and maintaining facility readiness. Clinical Lab Specialists use advanced training and expertise to produce clinical-grade cell therapy products, bispecific and monoclonal antibodies, recombinant proteins, lentiviral and retroviral vectors, and other reagents that support cGMP manufacturing. They work with minimal supervision, serve as a resource for non-routine issues, perform qualification testing to maintain clean-room cGMP facilities, and help ensure compliance with operational standards. The position is based in Charlottesville, Virginia, and is full-time and benefited. It is a restricted position whose continuation depends on funding and satisfactory performance.
Requirements
- Bachelor's degree in biological sciences, chemistry, or a related discipline.
- At least 1 year of laboratory research experience.
- Ability to perform the described standing, squatting, keyboarding, benchwork, and animal-procedure tasks requiring fine finger manipulation.
Nice To Haves
- Master's degree.
- At least 3 years of laboratory research experience.
- Experience in Good Laboratory Practice or Good Manufacturing Practice.
Responsibilities
- Specialize in cGMP methods and equipment functions specific to assigned projects.
- Work closely with the manager to ensure the sterility and composition of GMP products in the laboratory.
- Specialize in clinical manufacturing of therapeutic products in the cGMP facility.
- Perform quality control testing of cGMP products and samples with QA oversight.
- Assist the cGMP supervisor in maintaining compliance with FDA guidelines.
- Produce cell therapy, antibody, and other cGMP products with minimal supervision, following applicable SOPs and master batch records.
- Compile immune testing results on patient samples for analysis by the cGMP manager.
- Write and amend SOPs as needed.
- Enter clinical manufacturing data into the clinical manufacturing database.
- Compile quality control data reported by Cancer Immunotherapy Laboratory personnel for review with the manager.
- Assist in resolving manufacturing deviations by assessing impacts on product safety, identity, purity, and quality, and assist with investigations.
- Review qualification documents to ensure processes remain validated and meet regulatory commitments.
- Report quality control system performance, non-compliance issues, and recommended actions to management in a timely manner.
- Promptly communicate Quality Control Program or validation testing changes to the manager for authorization.
- Maintain equipment functionality, implement SOPs, and perform activities that support operational compliance and facility readiness.
- Perform qualification testing to maintain clean-room cGMP facilities.
Benefits
- Benefited position; UVA benefits are referenced in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
