GLP Study Director
About Metrion Biosciences
Metrion Biosciences (‘Metrion’) is a UK-based, ion channel focused Contract Research Organisation (CRO) providing high-quality in vitro preclinical drug discovery and safety profiling services. Formed in 2015, Metrion has since established a loyal and growing global customer base who access our comprehensive suite of drug discovery services; including medicinal chemistry screening support, cardiac safety profiling and custom assays using native tissue and stem cells. Metrion’s vision is to establish the company as the first-choice outsourcing partner for ion channel drug discovery research and cardiac safety services for the worldwide pharmaceutical industry.
The Study Director represents the single point of study control with ultimate responsibility for the overall scientific conduct of the study and ensures compliance with Good Laboratory Practice (GLP) regulations. This is the prime role of the Study Director, and all duties and responsibilities, as outlined in the GLP Principles, stem from it.
The position will involve management of Metrion Biosciences’ newly created GLP hERG laboratory. The candidate will be expected to work closely with Metrion’s management and business development teams to ensure studies are completed to expected turnaround times. Liaising with clients will also be a key aspect of the role.
GLP Study Director
Key responsibilities and accountabilities:
The Study Director is responsible for ensuring that GLP studies are
conducted in compliance with:
• UK GLP Regulations, SI 1999 No 3106; amendments, SI 2004 No. 994.
• No 1 OECD Principles on Good Laboratory Practice and Monographs.
• No 8 OECD The Role and Responsibilities of the Study Director in GLP Studies.
Activities undertaken by the GLP Study Director will include:
• Reading and understanding all relevant Standard Operating Procedures (SOPs) issued by the Document Controller and, if required, completing a Reading Record Form.
• Maintaining an understanding of the GLP regulations and OECD documents listed above, as well other relevant legal and regulatory documents.
• Maintaining an accurate and up-to-date training file.
• If required, assisting the business development team with preparing and issuing quotes for performing GLP studies.
• Interact with the Sponsor, Test Facility Management and, if relevant, the Test Site to enable the preparation of Study Plans.
• Approve Study Plans by signing and dating them and ensuring that they are signed by the Sponsor and Test Facility Management.
Essential Skills Qualifications:
Ideally the GLP Study Director should have:
• A BSc/MSc or PhD in a relevant subject area.
• At least three years’ experience of working in a GLP lab.
• Familiarity with manual patch-clamp electrophysiology
• At least two years of study director experience.
• Experience of performing manual patch clamp electrophysiology.
• Experience of working in a role that involves managing relationships with clients.
Do you have a passion for ion channel drug discovery?
If you have any questions that you would like to discuss regarding this vacancy or for an informal discussion about this role, please contact us today to discover more. We look forward to hearing from you.