JOB SUMMARY:

We are a high-growth digital in-vitro diagnostic start-up looking for a Head of Product to join our expanding team. You will be responsible for transitioning products from R&D to production to launch and will manage the laboratory operations at our QMS-13485 regulated lab in Cambridge. You will be a member of the executive management team working closely with the CEO to plan manufacturing strategy, operations and drive company growth. You enjoy working in a fast-paced dynamic environment and have a passion for digital technologies.

QUALIFICATIONS & EXPERIENCE REQUIRED

• Minimum 10 years experience working in manufacturing within diagnostic or medical device companies
• Minimum 5 years management experience, ideally managing a commercial laboratory
• Proficiency in quality systems (ISO 13485), associated documentation and processes
• Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
• Experience in tech transfer from R&D setting
• Experience in establishing and managing supply chains
• Experience in lateral flow device manufacturing a plus
• Experience of software as a medical device (SAMD) a plus
• Background in chemistry, particularly surface chemistry, a plus
• Strong communication skills
• Passionate about technology, healthcare and entrepreneurship
• Experienced in working in cross-functional teams
• Driven, motivated and organised
• Working independently with a high level of accountability

• Manage the laboratory operations
• Manage a team of production scientists
• Provide scientific insight, direct research to solve scientific problems
• Responsible for the technology transfer of production from R&D to production
• Responsible for supply chains and manufacturing
• Responsible for the completion of raw material specifications, in-process and out-sourced QC documentation and verification / validation processes in partnership with QA/RA director
• Ensure compliance of laboratory with QMS-13485
• Own the company’s manufacturing strategy and plan
• Responsible for scaling prototypes to higher launch volumes
• P&L responsibility for manufacturing function
• Monitor the industry landscape with a particular focus on incremental innovations applicable to our products
• Responsible for the life-cycle management of existing product