The UVA SOM is seeking applicants for a Lab Technician or Specialist in their GMP Core department. Responsibilities include coordinating the scheduling of clinical study samples, processing clinical samples, documenting and logging sample details, maintaining accurate records, shipping 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. They will support the manufacturing of clinical-grade cGMP products, including bispecific antibodies, monoclonal antibodies, recombinant proteins, AAV, lentiviral, and retroviral vectors.

Duties and Responsibilities:

• 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 FDA guidelines.

• Assist the cGMP manager in performing duties to maintain compliance with FACT guidelines.

• 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 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:

• Education & Experience: Associate's degree required plus 2 years of experience; Bachelor’s degree and 1 year of experience preferred; Master's degree in related science will be considered in lieu of experience.

Anticipated Hiring Range: $20 - $28/hour, commensurate with education and experience.

This position will not sponsor applicants already in the US for work visas. This is a restricted position; continuation is dependent on funding and satisfactory performance.

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.

The University will perform background checks on all new hires prior to employment. A completed health screen is required for this position.

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.

Application Process:

Please apply online, and search for R0084425. Internal applicants may search and apply for jobs on the UVA Internal Careers website. Complete an application online with the following documents:

• CV/Resume

• Cover Letter

Upload all materials into the resume submission field, multiple documents can be submitted into this one field. Alternatively, merge all documents into one PDF for submission. Applications that do not contain all the required documents will not receive full consideration.

References will be completed via UVA’s standardized process SkillSurvey. A total of five references will be requested via SkillSurvey during the final phase of the interview process. A minimum of three are required.

For information regarding the position or the application process, please contact Jessica Speth, Academic Recruiter, js9rk@virginia.edu.

Job Profile

J1883 - Laboratory Research Operations and Service 2

Career Stream and Level

Operations and Service-O2

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.