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. 

Requirements:

  • 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.

Qualifications:

  • 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 careers@tcr2.com