Production Scientist at Vital Signs Solutions
Location: Cambridge, UK
Salary: Competitive compensation package
Job summary:
We are a high-growth digital in-vitro diagnostic start-up looking for a Production Associate Scientist to join our expanding team. You will be part of the team responsible for transitioning products from R&D to production to launch within our QMS-13485 regulated lab in Cambridge. You will also work on life-cycle management projects for our existing brands bringing new innovations into our products.
You will have experience in working in a commercial production environment and have a background in surface chemistry. You will be able to perform experiments and analyse and interpret results independently. Experience working with lateral flow technologies would be a definite plus. You enjoy working in a fast-paced dynamic environment and have a passion for digital technologies.
Key Responsibilities
Conducting scientific experiments to improve existing technologies:
Improvements to existing chemical biomarker assays
Improvements to existing in-vitro diagnostic device parts
Precision and bias measurement
Performance evaluation validation studies
Stability assessment and optimisation
Responsible for production validation and verification experiments
Responsible for in-process QC experiments
Responsible for incoming goods control
Responsible for low-volume production
Member of team to transfer technology to out-sourcing providers
Lab management
Ordering of consumables
Maintaining inventory in labMaintenance of a clean safe working environment in accordance of GLP and ISO-13485
Scientific contributor
Analyzing and presenting data and results internally at R&D meetings
Presenting results and performing demonstrations to partners, clients and investors
Qualifications & Experience Required
PhD preferred
Degree in chemistry essential, knowledge of surface chemistry a plus
Minimum 3 years experience working in manufacturing within diagnostic or medical device companies
Proficiency in quality systems (ISO 13485), associated documentation and processes
Knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
Experience in tech transfer from R&D setting
Experience in lateral flow device manufacturing a plus
Experience of software as a medical device (SAMD) 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
Application process
To apply, please send (by e-mail) a cover letter demonstrating your suitability for this position, a detailed CV and the names and contact details of two academic referees to info@vitalsignssolutions.com