cGMP Lab Specialist – Cell Therapy Focus

University of Virginia; Charlottesville (VA); Sur place; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Full benefits

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

cGMP methods

lab techniques

QA oversight

Formation

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

Master’s degree preferred

Outils

SOPs proficiency

MBR familiarity

Description du poste

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