Quality Assurance Associate – Stevenage UK
TCR² Therapeutics Inc. is a clinical-stage immuno-oncology company developing the next generation of novel T cell therapies for patients suffering from cancer. Our proprietary TRuC™ (TCR Fusion Construct) T cells harness the natural T-cell receptor complex to recognize and kill cancer cells using the full power of T cell signaling pathways independent of HLA. TRuC-T cells have demonstrated superior anti-tumor activity in vivo compared to CAR-T cells while releasing lower levels of cytokines in preclinical studies. TCR² was founded by MPM Capital and is headquartered in Cambridge, MA to leverage best-in-class technologies and nucleate top-tier academic laboratories from around the world.
TCR² has embarked on establishing a cGMP manufacturing operation in Hertfordshire (Stevenage), UK to provide manufacturing capacity for Phase 1 and 2 clinical trials, and beyond, for TRuC™ T cell product candidates. The Quality Assurance Associate will support the manufacture and release of products under the Quality Management System environment, support product and batch record reviews, investigations into non-compliances, CAPA management, supplier qualification and documentation controls. This position offers an exciting opportunity to join the Stevenage team at an early stage.
Maintain quality supporting documentation to facilitate GMP production.
Assist in the preparation of manufacturing batch records for final review and QP lot release.
Review Change Control records impacting T cell therapy product.
Release documents and labels to the manufacturing production teams.
Provide investigational support of potential deviations for the manufacture, testing, and shipping events to and from the UK.
Write and revise quality associated documentation to support GMP production.
Support the quality management of suppliers, contractors and service providers.
Assist in providing training for GMP and GDP processing.
Assist in deviation review and implementation of CAPA to improve product quality.
Liaison with CGT Quality department on quality related issues.
Bachelor’s degree in the biological sciences or related field.
Minimum of 2 years GMP experience in a biotech, or biologics operation, or equivalent education/work experience.
Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS.
Prior experience in a quality function (quality assurance or quality control), preferably in a commercial environment.
Interested candidates should send their resume to firstname.lastname@example.org