Scientist, HPLC Medical Devices
Location: Liverpool initially, moving to Deeside (new site) – fuel allowance provided during this period
Type: Permanent
Hours: Days – Monday to Friday
Salary: Competitive DOE
Additional: Parking onsite, private medical, life assurance, company pension, attendance bonus
Our , a leading Medical Devices company – is expanding and looking to recruit for an experienced HPLC Scientist to work at their new site in Deeside (initially based at the existing site in Liverpool), this is a fantastic time to join this company.
Duties:
*To use specialised technical knowledge and skills in provision of analytical chemistry support (primarily HPLC quantification of antibacterial compounds in diagnostic devices) to contract antibiotic susceptibility testing studies according to the principles of CFR21 part 58 ‘Good laboratory practice for non-clinical studies’.
*To provide, in collaboration with Quality Assurance, internal sales and marketing teams, and external organisations, susceptibility testing device development and stability test services data of productcontainingnovel and/or combinatory antibiotics.
*To maintain records of all studies in compliance with certified and regulatory requirements, and to ensure prompt ing of studies to the sponsoring organisation and respond to any issues arising.
*Prepare and present written analytical method development s, validation s, test s and documents as directed, including Standard Operating Procedures, product technical files demonstrating product compliance with regulatory standards or directives, and s and documents for company policy and other meetings.Such s should usually be presented in an appropriate electronic format (e.g. Microsoft Word) and be suitable for inspection for external audit purposes.
*Participate in non-clinical GLP review, and specific meetings as requested by senior management or project sponsors, to discuss progress on the non-clinical studies undertaken.
*Develop, validate and embed analytical methods for testing of manufactured AST Diagnostic Devices and bespoke products developed during contracted non-clinical laboratory studies primarily, but not restricted to, HPLC analysis of antibiotic content.
*Maintain accurate and comprehensive records of results ensuring appropriate traceability from sample to raw data through to analysed results and including meticulous upkeep of a lab book containing detailed notes of all laboratory procedures undertaken.
*Maintain overview HPLC laboratory equipment and other analytical devices that may be specified in future including preparation of validated standard operating procedures for routine operation, cleaning and maintenance of Analytical equipment
*Develop, validate and embed analytical methods for testing of antibiotic content of existing AST products
*Support training of other laboratory staff at all levels in techniques and proper use of specialised analytical equipment such as HPLC
*Effectively transfer analytical methodology into routine quality control operations
*Provide technical training including oral presentations on courses held at Mast House, for sales and marketing, and laboratory personnel.
*In addition to the specified duties the Research & Development Scientist is expected to perform additional tasks that the company may require.
Qualifications and Experience:
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will be acting within your interest and will contact you in relation to the role, either by email, phone or text message. For more information see our Privacy Policy on our website. It is important you are aware of your individual rights and the provisions the company has put in place to protect your data. If you would like further information on the policy or GDPR please get in touch with us here.
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