Manager, Contract Manufacturing and Process Engineering

Description of role

  • Together with COO/CTO and others defines the manufacturing strategy for the company and selection of critical contract manufacturers, critical component manufacturers, critical equipment manufacturers and critical materials.
  • Ensures appropriate contracts and agreements are in place.
  • Together with the contract manufacturer develops the manufacturing process with focus on design for manufacturing.
  • Transfers existing processes as determined to contract manufacturer.
  • Together with contract manufacturer defines critical to quality parameters and sets up key process performance indicators.
  • Monitors performance of key contract manufacturers.
  • Supports contract manufacturers in the providing solutions to issues and process challenges.
  • Works to define the appropriate process, controls, and equipment to complete all required internal reagent manufacturing requirements
  • Ensures all equipment, processes and test methods are validated in accordance with appropriate quality and regulatory standards.
  • Responsible for the creation of the Device Master Record in accordance with quality and regulatory requirements.
  • Assists the in developing the appropriate quality system procedures, manufacturing work instructions and records in accordance with ISO13485:2016 and the FDA Quality System Regulation.
  • Hires and leads high performing teams.
  • Implements Lean principles.

Aptitude required

  • Ability to influence and work as a team to deliver goals
  • Strong communication skill
  • Organised and execution oriented.
  • High accountability to deliver on commitments.

Qualifications

  • Must have a minimum of 5 years’ experience of manufacturing In-Vitro Diagnostics or Medical Devices. Benefit from having direct experience with the manufacture of critical Regents
  • 15+ years of Manufacturing experience in a regulated environment with experience in manufacturing under ISO13485:2016 and FDA Quality System Regulation
  • 3+ years’ experience of implementing Lean Principles within a regulated manufacturing environment
  • Educated to Degree Level in Manufacturing or Engineering Discipline.

If you are interested, then please send a covering letter and CV for the attention of Helen Armes to h.armes@biocrucible.co.uk