Senior Study Director LCMS
Salary Very competitive
CY Partners are recruiting for a Senior Study Director LC-MS to join a successful and expanding specialist contract laboratory.
This will be based at their state of the art laboratories on the outskirts of York.
Competitive salary and benefits.
Senior Study Director role:
As a Senior Study Director you will direct bioanalytical studies, contribute to bioanalytical scientific and regulatory strategies and mentor junior Bioanalysts and Study Directors.
Key duties will include:
• Delivery of Bioanalysis – As the Senior Study Director , you will be responsible for different study types (method validation, analytical and equipment validation studies) as well as supervise staff performing the laboratory work; draft study and validation protocols, review all study data for accuracy and GLP / GCP compliance as well as writing study reports.
• Personnel Training and Development – As the Senior Study Director, you will be responsible for performing quantitative analysis using LC-MS whilst providing assistance in the technical, scientific, practical and GLP and GCP compliance of all work in the company.
• LC-MS bioanalysis platforms / processes – Where required evaluate and establish operation of new LC-MS platforms and supporting equipment. Maintain and build upon industry leading processes to ensure the highest quality and efficiency is achieved.
Experience / Skills required:
• Strong background in the development of LC-MS bioanalysis methods in support of PK and Biomarkers
• Demonstrable study directing experience in a clinical and/or preclinical bioanalysis laboratory.
• Strong background in support of regulatory validation and sample analysis studies
• Experience in a regulatory environment and in directing regulated studies, experience working to GLP and GCP standards
• Experience in a client facing role with the ability to provide high level advice and guidance to clients
• Experience of driving the introduction of new instruments, processes and best in class practices
• Experience in receiving regulatory inspections/questions in relation to performed studies.
This is an exciting opportunity to work as a key member of a successful, expanding organisation. If this position is of interest, apply now or contact Dan Younger at CY Partners to discuss in more detail.