Scientist, Manufacturing – 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 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 manufacture 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.
Manage and maintain a GMP manufacturing facility to meet FDA, EU and MHRA guidelines.
Supervise and work with the core manufacturing teams in a cleanroom environment.
Serve as the technical resource for the manufacturing process.
Ensure conformity to the Quality Management System.
Prepare, review and revise SOPs and manufacturing reports.
Liaise with the Facility Management for coordination of manufacturing activities and warehousing of raw materials.
Review manufacturing records.
Ph. D. in biological sciences or related field and minimum of 3 years progressive experience in a cell therapy or related field in GMP manufacturing.
Experience with T cell therapy manufacturing preferred or an strong immunology background.
Familiarity with GMPs in conformance with EU, FDA and MHRA standards.
Outstanding interpersonal communication and organizational skills.
Interested candidates should send their resume to firstname.lastname@example.org