Clinical Lab Specialist

University of Virginia; Charlottesville (VA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Full benefits

Job summary

The University of Virginia (UVA) School of Medicine seeks a Clinical Lab Specialist to support cGMP clinical manufacturing and immune testing for product release under supervision. The role emphasizes maintaining equipment, SOP implementation, and compliance in a high-regulatory environment in Charlottesville, VA.

The position involves producing clinical-grade cell therapy products, antibodies and other cGMP materials, entering data, writing SOPs, and contributing to investigations and

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.

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 SOPs and MBRs.
• 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 impact on product safety, identity, purity and quality and assists with investigations.
• Reviews qualification documents to ensure processes remain validated and within regulatory commitments.
• Reports in a timely basis to management on QC system performance, non-compliances, and recommended actions.

Skills

cGMP methods

lab techniques

QA oversight

Education

Bachelor's degree in biological sciences, chemistry or related discipline

Master’s degree preferred

Tools

SOPs proficiency

MBR familiarity

Job description

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.

Job Description

• 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.

Qualification And Experience

• 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.

This position is located in Charlottesville, Virginia. This is a full-time benefited position. For more information on the benefits at UVA, visit www.hr.virginia.edu/benefits.

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.

The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment.