Manufacturing Senior Scientist
£35k - £40k per annum An exciting and innovative diagnostics organisation are hiring both a Manufacturing Scientist and Manufacturing Senior Scientist for their new site on the Cambridge Science Park.
You will become part of an experienced and established small team of industry professionals working in the molecular diagnostics space, and integral in the development and progression of unique tools to support the diagnosis of infectious disease as well as neurodegenerative disease.Working to stringent ISO 13485 protocols, with GMP and GLP manufacturing processes, the core role requirements include, but are not limited to:
* Develop, maintain and comply with the manufacturing process for a suite of CE marked IVD products
* Perform all elements of the product manufacturing process in line with SOPs, update accordingly on the LIMS and QMS any errors or non-conformances and report discrepancies
* Contribute to and support the generation of batch traceability data
* Internal auditor of the organisation's products, processes and systems - seeking to suggest and evidence ways to improve on these
* Be an active contributor to the BSI ISO 13485 audit preparations and delivery of successful audit campaigns
* Contribute to the daily running of the manufacturing facility to include equipment verification and validation
* For the Senior Scientist: you will be expected to supervise others in the Lab for 1-2 days a week in the absence of the Lab Manager. Supervisory experience is preferable but not essential as long as you have the keen desire to step up and take on this responsibility and competencies to auger well for it Your background:
* BSc or equivalent in a Biology-based discipline such as: Molecular Biology, Microbiology, Genetics, Biochemistry or Biotechnology for example
* Familiarity and good working knowledge of working to ISO 13485 and or GMP/GLP protocols relating to IVD products
* Accustomed to working in small and busy teams of multidisciplinary staff
* Agile in your approach, able to plan and prioritise effectively taking into account the wider business needs, with excellent communication skills, both written and verbal If either the Scientist or Senior Scientist role sounds like a good next move for you, please contact Bec Johnston: firstname.lastname@example.org / 01223 607858 for a confidential conversation about these opportunities.
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