David Hellier Email and Phone Number
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A wealth of experience gathered from working in complex start-up environments, built on a solid foundation of product development, manufacturing and team leadership expertise have been the core pillars of my career thus far. More than two decades of knowledge in establishing processes for medical devices, across a broad spectrum and in line with all relevant quality and regulatory requirements. I thrive on bridging the gap between technical troubleshooting and compliant manufacturing of innovative products whilst building relationships across the board and having a relentless work ethic to do what’s necessary to help start-ups and small businesses reach the next level of their life cycle.
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Chief Operations OfficerGlobal Access Dx (Gadx)Cambridge, Cambridgeshire, United Kingdom
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Head Of Manufacturing And Technology Transfer OperationsGlobal Access Dx (Gadx) 2024 - PresentThurleigh, Bedfordshire, Gb -
Professional Advisory ServicesVarious 2023 - Present
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Contract Manufacturing ManagerBiocrucible 2022 - 2023Cambridge, GbJoined this UK-based molecular diagnostic company to lead the development of manufacturing. Highlights included:• Established relationships with Contract Manufacturers for injection moulding, PCB manufacture, and full device assembly.• Played an active leadership role in scoping and defining organisational culture as the company grew from ~20 to 60 in 2022.• Implemented 5S, trained out Value Stream Mapping process, and began to implement other LEAN methodologies within the operational functions. -
Technical Lead - Operations ManagerBespak 2020 - 2021Holmes Chapel, England, GbJoined this global market leader providing pharmaceutical companies with injection moulded devices, this was to take the lead on a Point of care diagnostic device. Highlights included:• Worked as part of a high-quality team at Bespak to move a key product to full production, whilst navigating the complex environments presented to us during the Covid-19 pandemic. • Accountable for the technical elements of a successful product transfer to production and commercial launch for a start-up organisation, matrix managing a team of circa 95 staff. • Carried out technical development of the manufacturing process and managed steps to take the product from validation through to a highly successful commercial launch.• Accountable for ensuring effective systems and processes established across Quality, production, supply chain and engineering functions. • Successfully achieved process validation by the end of 2020, allowing for product commercial launch. -
Principal Engineer To Manufacturing ManagerCmr Surgical 2017 - 2019Cambridge, GbAppointed to lead the transition from research and development to manufacturing for this innovative medical device organisation dedicated to transforming surgery using a next-generation surgical robot.• Built the first Manufacturing and Manufacturing Engineering teams, growing the team to 30 members in 2.5 years while establishing effective processes and people culture. • Successfully managed the set-up of the manufacturing process and production space within the new site in Q3 2018 and managed the transfer of the production process and team. -
Manufacturing ManagerNear Patient Testing Unit At Novartis 2013 - 2016Basel, Baselstadt, ChAppointed to establish a commercial manufacturing facility and move the product life cycle from design into mainstream manufacturing. • Manufacturing was completed to cGMP, under ISO 13485 quality system requirements. • Responsible for receiving R&D projects into production and moved to a new building following its completion and installation of a clean room. -
Process Development EngineerVivacta (Diagnostic Medical Device Startup) 2010 - 2013Gb -
Various Roles Including Production Team LeaderOxoid 2000 - 2009Gb
David Hellier Skills
David Hellier Education Details
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The Open UniversityBusiness Administration -
Anglia Ruskin UniversityMicrobiology
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Cambridge Regional CollegeUnderstanding Mental Health First Aid And Mental Health Advocacy In The Workplace
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The Open UniversityProblem Solving And Improvement (T889)
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Anglia Ruskin UniversityApplied Biology
Frequently Asked Questions about David Hellier
What company does David Hellier work for?
David Hellier works for Global Access Dx (Gadx)
What is David Hellier's role at the current company?
David Hellier's current role is Chief Operations Officer.
What is David Hellier's email address?
David Hellier's email address is da****@****x.co.uk
What is David Hellier's direct phone number?
David Hellier's direct phone number is +4475459*****
What schools did David Hellier attend?
David Hellier attended The Open University, Anglia Ruskin University, Cambridge Regional College, The Open University, Anglia Ruskin University.
What skills is David Hellier known for?
David Hellier has skills like Immunoassays, Elisa, Medical Diagnostics, Process Improvement, Manufacturing, Team Management, Production Planning, Product Validation, Quality, Auditing, Medical Devices, Process Validation.
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