Job Description

Through continued growth and continued new product innovation, we are seeking a self-confident, well organised, experienced scientist with interest in Molecular Genetics and commercial development. The successful Candidate will join a developing SME working both in in-vitro diagnostics, reagent/ device manufacturing; taking a key position early in the company's expansion through participation in the start-up of new facilities.

Note this is a flexible position, inc. work at home and hours where necessary.

The Role

Providing scientific support for new and existing products and processes by:

• Implementation of process and product transfer from R&D; to GMP standard (including relevant compliance).
• Assisting in the design/manufacture of IVD reagents.
• Completion of quality documents, reports and investigations.
• Working cross functionally within the Lab and Office where necessary (using complex Laboratory based Instrumentation).
• Specifying, sourcing and qualifying materials & equipment.
• Continuous improvement of existing processes.
• Generation of batch documentation.
• Contribute to the development of novel and existing products and processes by the production of high quality scientific data.
• Ensure Good Practice (GLP) is followed and all areas are maintained to the appropriate standards.
• Keep abreast of relevant new technologies.
• Record all experimental and processing outcomes in an appropriate format.
• Identify and escalate promptly any problems occurring at any phase of a study/project

The Person

• Will hold a Degree in a Scientific or relevant discipline (or have demonstrated key experience highlighted below)
• Experience and interest in NIPT design including data analytics
• Preferable knowledge of GMP and GLP requirements.
• Preferable experience working across process and product transfer within a related GMP environment/Pharmaceutical or Device industries.
• Will have a good grasp of Laboratory based test work using a number of Analytical techniques/instrumentation.
• Preferable practical experience in a range of scientific skills and technologies (inc NGS, PCR, bioinformatics).
• Knowledge/understanding of qualification and validation requirements
• We want Candidates who have career drive and strong interpersonal skills, to enable them to progress and to coach other less senior members of the team as it grows.
• Responsible to act as Laboratory Manager in absentee.
• Proactive, independently productive, self-critical, multi-tasking, up for a challenge in a growing international Dx SME.