Clinical Lab Specialist

University of Virginia•Charlottesville, VA

5d•Onsite

About The Position

UVA School of Medicine is seeking a Clinical Lab Specialist. This position provides manufacturing of clinical cGMP products, and technical lab support through immune testing for the release of products under the supervision of the cGMP supervisor or director. Clinical Lab Specialist employees support clinical manufacturing operations in a cGMP environment by maintaining equipment functionality, implementing SOPs, and performing activities that ensure operational compliance and facility readiness. Distinguished from Lab Technicians by their advanced training and expertise, they contribute to the manufacturing of FDA-approved clinical products used to treat cancer and other diseases and serve as a resource for non-routine issues. Working with minimal supervision, Clinical Lab Specialists produce clinical-grade cell therapy products, bispecific and monoclonal antibodies, recombinant proteins, lentiviral and retroviral vectors, and other reagents supporting cGMP manufacturing. They also perform qualification testing to maintain clean room cGMP facilities and ensure compliance with operational standards.

Requirements

Bachelor's Degree in biological sciences, chemistry or related discipline
At least 1 year of experience in laboratory research
Experience in Good Laboratory Practice or Good Manufacturing Practice

Nice To Haves

Master’s preferred
3+ years preferred experience in laboratory research

Responsibilities

Specialize in cGMP methods and equipment functions specific to projects.
Works closely with manager to ensure sterility and composition of all GMP products within 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 performing duties to maintain compliance with FDA guidelines.
Produce cell therapy, antibody, and other cGMP products with minimal supervision and is proficient with the standard operating procedures (SOP) and master batch records (MBR) needed to produce the product assigned.
Able to compile immune testing results on patient samples for analysis by cGMP manager.
Write and amend new SOPs as needed.
Enter clinical manufacturing data into the clinical manufacturing database.
Compiles all quality control data reported by Cancer Immunotherapy Laboratory personnel for review with manager.
Assists with resolution to manufacturing deviations by assessing the impact on product safety, identity, purity and quality and assists with the investigations.
Reviews qualification documents to ensure that processes remain in a validated state and within regulatory commitments.
Reports in a timely basis to the management on the performance of the quality control system, any non-compliance issues, and recommended actions. Promptly communicates Quality Control Program or validation testing changes to manager for authorization.