Contract Manufacturing Manager

2 weeks ago

Cambridge Cambridgeshire, United Kingdom LEX Diagnostics Full time

Job Description

LEX Diagnostics is currently hiring for a Contract Manufacturing Project Manager to join the LEX team. This is an important position with the LEX team as you will be responsible for leading the transfer of products to our contract manufacturing organisations (CMO’s). As well as building strong working relationships with our CMO’s to ensure production and processes are validated and manufactured to the required standards, you’ll also work closely with our Engineering, Biology and Quality departments to create and execute manufacturing scale up plans for the LEX system.

LEX Diagnostics is an ambitious, well-funded point-of-care diagnostics business. We believe that fast, accessible molecular diagnostics will have a fundamental impact on how infectious diseases are managed at point of care and beyond. Our technology is uniquely able to address this challenge and we are commercialising it with partners who share our ambition. You can read more about LEX here.

To succeed in this role, you'll need to be familiar with the demands of working in a regulated medical device manufacturing environment as, you’ll play a key part in ensuring that contract manufacturers can scale capacity to meet the business requirements.

Responsibilities will include:

  • Manage the relationship between LEX and Contract Manufacturing Organisations (CMOs) responsible for producing the LEX instrument and consumables.
  • Collaborate with the manufacturing, engineering, biology, program management, and external partners, to align with the launch plan.
  • Maintain strict adherence to ISO 13485/FDA regulations across all activities.

Following skills and experience required to be successful in this role:

  • Previous experience of contract manufacturing of In Vitro Diagnostic (IVD) devices in a ISO13485/FDA regulated environment.
  • Strong communication skills and confident at building and managing relationships internally and externally.
  • If you have a Science of Engineering degree or equivalent experience then this would be advantageous.

LEX Diagnostics is part of TTP Group, an employee-owned business. It operates from green surroundings in Melbourn, less than 10 miles south of Cambridge. TTP Group takes a long-term approach to investment and has been at the forefront of point-of-care diagnostics for over 20 years. Drawing upon the expertise of its consultants in the Life Science sector, and the management experience of a company with a 30-year track record of developing breakthrough technology and creating ambitious tech businesses, TTP Group invested core IP and staff into LEX in 2020.

Our benefits include:

  • Annual profit-related bonus
  • Employer pension contribution of 12% of pensionable pay
  • Private medical insurance for employees and dependants
  • Free lunch and all-day refreshments
  • Life insurance worth 6 x salary
  • 25 days holiday with the option to carry over or bring forward 5 days
  • Enhanced maternity and paternity leave, with the option to return part-time for a year
  • Electric car leasing scheme
  • Cycle to work scheme
  • Public Transport Season ticket loan
  • A wide range of social clubs and activities including squash, Zumba, yoga, arts and crafts and even our own rock band
  • Local sports facilities and theatre discounts and memberships as well as our own onsite gym to use

This is an exciting opportunity within the LEX Diagnostics team and to help and support us with achieving our goal to commercialisation. If you’re looking to join a diverse and growing team, then apply now

Every application will receive a response.

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