Clinical Lab Specialist

About the role

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.

Responsibilities

• Specialize in cGMP methods and equipment functions specific to projects
• Work 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
• Compile all quality control data reported by Cancer Immunotherapy Laboratory personnel for review with manager
• Assist with resolution to manufacturing deviations by assessing the impact on product safety, identity, purity and quality and assists with the investigations
• Review qualification documents to ensure that processes remain in a validated state and within regulatory commitments
• Report in a timely basis to the management on the performance of the quality control system, any non-compliance issues, and recommended actions
• Promptly communicate Quality Control Program or validation testing changes to manager for authorization

Qualifications

• Bachelor's Degree in biological sciences, chemistry or related discipline; Master's preferred
• At least 1 year of experience in laboratory research; 3+ years preferred
• Experience in Good Laboratory Practice or Good Manufacturing Practice preferred

Physical Demands

This position can spend extensive periods of time standing and squatting while conducting experiments or caring for animals. Also requires keyboarding and other benchwork and animal procedures requiring fine finger manipulation.

Position Details

This position is located in Charlottesville, Virginia. This is a full-time benefited position. This is a restricted position; continuation is dependent on funding and satisfactory performance. Visa sponsorship is not available for this role. The University will perform background checks on all new hires prior to employment. A completed pre-employment health screen and drug screening is required for this position prior to employment.