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Operations Manager

Employer
TCR² Therapeutics Inc.
Location
UK
Salary
Competitive
Closing date
26 Jul 2021

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Sector
Engineering
Contract Type
Permanent
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Job Details

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 signalling 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 the UK at Stevenage, Hertfordshire, to provide manufacturing capacity for Phase 1 and Phase 2 operations, and beyond, for the TRuCTM T cell platform. The Operations Manager will report to the VP of Manufacturing and will support all site functions with regards to facilities administration, equipment and asset management, management of IT providers and lead site health and safety matters. This position offers an exciting opportunity to join the Stevenage team at an early stage, to deliver life saving therapies to cancer patients across a broad class of indications.

Responsibilities:
  • Manage the GMP and non-GMP facilities at Stevenage to provide a safe and productive working environment for all staff, contractors and visitors
  • Act as the primary interface with facilities and engineering teams at CGT Catapult, Stevenage Bioscience Catalyst and Kadans Science Partners
  • Lead facility expansion and improvement projects to agreed schedules and act as the primary interface with landlords and third parties involved in build programs
  • Manage asset management to include equipment metrology, scheduling and execution, planned maintenance and repair with suppliers and service providers and liaise with the finance team to meet company policies and compliance requirements
  • Manage IT service providers for software and hardware needs for both GMP and non-GMP operations
  • Act as a technical expert for cleanroom and laboratory design and operation and support manufacturing and QC teams in investigations and CAPAs
  • Oversee facilities expenses and reporting for rent, services, insurance and energy for all building to agreed budgets
  • Act as the Health and Safety representative for the company as required by the UK Health and Safety Executive, chair company health and safety meetings and manage external Health and Safety consultants and provide appropriate training and support for all staff
Requirements:
  • Bachelor's degree in a biological sciences or related field and minimum of 8 years progressive experience in pharmaceutical, biotech, or biologics operations and facilities management
  • Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU and ICH standards
  • Experience and involvement in external regulatory inspections an advantage
  • Experience and knowledge in dealing with Health and Safety issues
  • Ability to effectively negotiate and build collaboration with third parties and service providers
  • Good interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced small company environment with minimal direction.
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