Good Manufacturing Practice Facility (GMP) is looking for Lab Specialist or Lab Specialist Intermediate. This position will perform routine and complex tasks independently or with minimal supervision. Responsibilities include coordinating the scheduling of clinical study samples, documenting and logging sample details, processing samples, maintaining accurate records, and tracking results. Additional responsibilities include assisting with qualification testing to ensure the cleanroom and related cGMP facilities meet regulatory requirements. The role also involves supporting equipment maintenance, implementing standard operating procedures (SOPs), and ensuring compliance with FDA-regulated operational standards. The Lab Specialist is expected to maintain the necessary technical expertise and serve as a resource in addressing non-routine or complex issues as they arise. This position will support the manufacturing of clinical-grade cGMP products, including bispecific antibodies, monoclonal antibodies, recombinant proteins, AAV, lentiviral, and retroviral vectors.

Assist to coordinate scheduling of clinical study samples, documenting/logging sample details, sample processing, sample shipping, record and track results.Specialize in lab and/or other research methods and equipment functions specific to cGMP labs. Perform a variety of tests requiring a high degree of   proficiency.Specialize in clinical manufacturing of cGMP grade products in the cGMP facility.Perform Quality Control testing of cGMP products and samples with QA oversight.Assist the cGMP manager in performing duties to maintain compliance with FDAguidelines.Assist in producing clinical grade therapeutic cGMP products following standard operating procedures and master batch records.Train and explain work instructions to new staff and may adapt general methods and procedures in order to meet the needs of the cGMP facility.Enter clinical sample processing data into the database.In addition to the above job responsibilities, other duties may be assigned.

MINIMUM REQUIREMENTS

Lab Specialist

Education: Bachelor's degree.
Experience: 2 years of experience. 4 years of lab-related experience accepted in lieu of degree.
 

Lab Specialist Intermediate

Education: Bachelor's degree.
Experience: 4 years of experience. Master's degree may substitute for required experience. 8 years of lab-related experience accepted in lieu of degree.

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 bench work and animal procedures requiring finer finger manipulation.  

Salary will be commensurate with education and experience. Learn more about UVA benefits. This is a restricted position, which is dependent on funding and is contingent upon funding availability.

This position is based in Charlottesville, VA, and must be performed fully on-site. To learn more about UVA and in the Charlottesville area, visit UVA Life and Embark CVA.

Background checks and pre-employment health screenings will be conducted on all new hires prior to employment.

HOW TO APPLY

Please apply online, by searching for requisition number R0075203. Complete an application with the following documents:  

ResumeCover Letter

Upload all materials into the resume submission field. You can submit multiple documents into this one field or combine them into one PDF. Applications without all required documents will not receive full consideration.

Internal applicants: Apply through your Workday profile by searching “Find Jobs.”

Reference checks will be completed by UVA’s third-party partner, SkillSurvey, during the final phase of the interview. For questions about the application process, please contact Jeremy Brofft, Senior Recruiter at xmf9ad@virginia.edu.

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