Microbiology Scientist, AST/Pharma

Microbiology Scientist, AST/Pharma
Type: Fixed term contract 12 months (has the potential to go permanent)
Location: -Liverpool
Hours/Shifts: -Monday- Friday (days)
Additional: - 23 holidays + BH, Attendance Bonus, Private Medical, Company Pension etc.
Responsibilities
• Responsible for carrying out existing and new product development activities as agreed under the general supervision of the line manager. All activities are to be conducted to the agreed scientific and regulatory standard or directives e.g. European IVDD and IVDR of the department and promptly reporting deviations from stated targets of performance.
• Responsible, with minimum supervision, for conducting reviews of literature related to investigations being undertaken, conducting and, where necessary, enhancing experimental design, carrying out research studies, analysis of experimental data, reporting of studies in the form of a written report as per laboratory standards and ensuring raw materials are available as required for investigative studies,
• Responsible for performing scientific and documentary activities related to regulatory requirements e.g. European IVDD and IVDR, to the agreed scientific and regulatory standards and promptly reporting deviations.
• Responsible for the collation of reference information relevant to all investigations and for the correct maintenance and updating of technical records in appropriate project files for allocated projects.
• To participate in laboratory project meetings where technical matters affecting current projects and present results are discussed and to provide assistance to senior staff in technical training for Sales and Marketing and laboratory personnel.
• To provide cover for the team, as agreed between the Quality Control and R&D Managers when necessary.
• Prepare and present written reports and documents as directed, including the preparation and updating of Standard Operating Procedures, technical dossiers demonstrating product compliance with regulatory standards or directives, reports and documents for company policy and other meetings. Such reports should usually be presented in an appropriate electronic format (e.g. Microsoft Word).
• In addition to the specified duties the Scientist is expected to perform additional tasks that the company may require.
The Person
• BSc or equivalent a scientific - life sciences related discipline
• The ideal candidate will have worked in an AST setting; handling bacterial cultures to Class II & antibiotic susceptibility testing, gram staining, inoculations, bioburden & cell culturing.
• Method validation experience is preferred.
• Experience working in a regulated environment is essential, ideally ISO 13485 and IVDR or 2nd choice would be ISO 9001 or ISO 15189, GMP/ GLP etc.
• Report writing/ technical file writing experience preferred.
• Experience in experimental design, product design transfer & data analysis.
• Strong interpersonal & report witing skills.
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