Scientist, Quality Control – 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 for TRuC™ T cell product candidates.  The role that TCR² envisions is a Quality Control Scientist with strong and demonstrable leadership skills that will be utilized in a manufacturing program at Catapult Cell and Gene Therapy Center.   

The successful candidate will join the Manufacturing Group to lead a team to qualify and perform quality control assays on genetically engineered T cell products.  This position offers an exciting opportunity be responsible for a key aspect of TCR² overall corporate strategy.

Responsibilities:

  • Supervise the QC laboratory buildout and qualification of essential equipment.

  • Train and manage quality control associates.

  • Design and implement assay qualification protocols for final product and in-process testing.  Examples of proposed assays: flow cytometry, qPCR, endotoxin, and sterility (BACTALERT®).

  • Prepare, review and revise SOPs and protocols.

  • Prepare and review certificate of analysis or reports for review by Quality Assurance.

  • Liaise with the Facility Management for coordination of manufacturing activities and warehousing of raw materials.

Requirements:

  • M.S. or Ph. D. in biological sciences or related field and minimum of 3 years progressive experience in a cell therapy or related field in quality control.

  • Demonstrated experience in establishment, qualification and validation of assays related to cell therapy product such as flow cytometry and qPCR. 

  • Demonstrable knowledge and ability to apply GLPs in conformance with EU, FDA and/or ICH standards.

  • Outstanding interpersonal communication and organizational skills.

  • Ability to effectively negotiate and build collaboration amongst individuals.

  • Comfortable in a fast-paced small company environment with minimal direction.

Interested candidates should send their resume to careers@tcr2.com