Lab Technician/Specialist
About The Position
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.
Requirements
- 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
- Must have a completed health screen
Nice To Haves
- Bachelor's degree and 1 year of experience preferred
- Master's degree in related science will be considered in lieu of experience
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.
- Other duties may be assigned.
Benefits
- Full-time benefited position
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
