Operations Manager – 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 (Stevenege), 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 Logistics and Operations Manager with strong and demonstrable leadership skills that will be utilized to outfit and establish a manufacturing program in a shell space at Catapult Cell and Gene Therapy Center.
The successful candidate will join the Manufacturing Group to buildout the facility, hire and lead a team from the ground up 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.
Coordinate facility buildout and equipment qualification to meet FDA, EU and MHRA guidelines.
Plan and manage supply chain and inventory control for GMP materials.
Optimize internal manufacturing capacity via coordination with CGT warehouse and scheduling teams.
Liaise with the clinical teams to determine scheduling of manufacturing slots
Oversee Chain of Identity, Chain of Custody and import/export permits for final products.
Coordinate with the Production Manager to ensure conformity to the Quality Management System and release drug products in a timely manner.
Serve as the technical resource for equipment and systems qualification and operation
Hire and train the core manufacturing and quality control teams.
Prepare, review and revise SOPs and protocols related to the manufacturing process equipment and systems.
Review manufacturing and quality control records as needed
Assist in the forecasting budget and determine resource requirements
Ph. D. in biological sciences or related field and minimum of 7 years progressive experience in a cell therapy or related field in GMP manufacturing.
Expert knowledge and ability to apply GMPs in conformance with EU, FDA and/or ICH standards.
Experience with supply management.
Outstanding interpersonal communication and organizational skills.
Ability to effectively negotiate and build collaboration among individuals.
Comfortable in a fast-paced small company environment with minimal direction.
Interested candidates should send their resume to email@example.com