The role is covered in the following locations: Liverpool
We're working with an independent world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing.
JOB TITLE - Laboratory Scientist
REPORTING TO - Team Lead or Section Manager
PURPOSE AND OBJECTIVES:
- To use specialised technical knowledge and skills to work on the development, documentation and evaluation of new products.
- To perform investigations related to the improvement of existing products and to investigate resolution of manufacturing issues.
- To apply a good understanding of QA, GMP, IVD Directive (IVDD) and Regulation (IVDR), ISO 9001 and ISO 13485 guidelines to Mast Group products, allowing them to meet regulatory and market requirements and to generate significant profit for the company over their lifecycle.
Key Duties and Responsibilities
SUMMARY OF MAIN RESPONSIBILITIES AND ACTIVITIES:
- To be 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.
- To be responsible, 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,
- To be 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.
- To ensure products are designed and manufactured with sufficient robustness, so they do not compromise the health and safety of patients, users and third parties and attain the performance levels specified by the manufacturer.
- To be responsible for ensuring all activities are carried out in accordance with Company design policies.
- To be 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.
- To provide assistance to senior staff in technical training for Sales and Marketing and laboratory personnel.
- To provide cover for Quality Control staff, 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 Laboratory Scientist is expected to perform additional tasks that the company may require.
- Degree in Molecular or Micro Biology
- A year minimum post degree lab experience
- Competitive base salary dependent on experience
- Attendance bonus
- 23 days holiday + bank holiday
- 1 week attendance bonus every quarter
- Life Assurance x2 - then goes 4 times