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.
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
- 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.