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. 

Responsibilities:

  • 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

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 careers@tcr2.com