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 by offering life saving therapies to cancer patients across a broad class of indications.
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.
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 firstname.lastname@example.org