Our client is a well-established and highly respected manufacturer of PCR-based IVD tests for infectious diseases, which can be used on a point-of-use basis for immediate diagnosis. Due to further expansion, they now wish to appoint an experienced Laboratory Manager.
In this key role, you will be responsible for laboratory operations and maintenance. You will ensure that the principles of Good Clinical Laboratory Practice, Good Manufacturing Practice, and Good Documentation Practice (GxP) are maintained, and for ensuring overall compliance to ISO 13485.
You will report to the Director of Research & Development:-
Equipment verification and validation (IQ, OQ, PQ) and management;
Responsible for environmental monitoring control and administration (Tutela);
Maintenance of service records, calibration dates and validation logs in respect of all laboratory equipment;
Maintenance and management of cleaning rota;
Undertake Risk Assessments/COSHH assessments for the laboratories and ensure the company’s Health & Safety policies are adhered to;
Timely liaising with suppliers to organise repairs, calibration, repairs etc. of all laboratory equipment;
Lead trainer for R&D department personnel;
Act as Laboratory Management Subject Matter Expert (SME) in respect of audits;
Ensure the proper handling, storage and disposal of hazardous materials;
Ensure that all personnel are using the laboratory safely (including containment laboratory) and adhering to safety policies and procedures;
Management of R&D instrument databases and lab data acquisition computers;
It is anticipated that the role will account for approximately 50% of your time. With the remainder, as a competent molecular biologist you will have the opportunity to impact on a number of our product development programs.
They are looking for a person who can demonstrate the following competencies:-
Laboratory management experience, gained in a quality compliant environment (GcLP, ISO 13485);
Strong experience with database, asset and electronic quality management systems (e.g. Qpulse);
Competent working with high content data analytics; ability to analyse, interpret and clearly document data;
Strong experience with equipment verification and validation;
Experience with COSHH and Risk assessment management;
Solid understanding of containment control for amplicons, and pathogens;
Good knowledge, understanding and practical experience of molecular biology and PCR;
Excellent knowledge of laboratory equipment and processes;
Good organisational skills.
You should have a BSc/MSc degree or equivalent in a Life Sciences discipline and a minimum of 5 years related experience (or equivalent experience).