Role: PK Study Director LC-MS
Salary: Highly competitive
Russell Taylor Group has a fantastic opportunity for a Study Director who specialises in bio-analysis, LC-MS / PK studies. You will also have experience in LCMS Method Development / Validation and worked within a GLP and GCP environment.
- Responsible for different study types (validation, analytical and equipment studies)
- Supervise staff performing the lab work, any draft studies and validation
- Responsible for reviewing all study data for GLP / GCP compliance
- You will transfer all study data into reports
- Performing quantitative analysis using LC-MS and multiplied immunoassays
- Provide assistance in the technical, scientific, practical, GLP / GCP compliance throughout the business
- Evaluate and establish operation of LC-MS platforms and supporting equipment
- Maintain and build upon industry leading processes to ensure the highest quality and efficiency is achieved
- A minimum of 2 years' appropriate experience in clinical and/or preclinical bioanalysis laboratory.
- Strong background in the development of LC-MS bioanalysis methods in support of PK and Biomarkers
- Strong background in support of regulatory validation and sample analysis studies
- Experience in a regulatory environment and in directing regulated studies, experience working with GLP and GCP
- 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
- Proven Industry Experience in Study Directing - Previous Study Directing experience within a GCP/GLP laboratory is essential. Individuals with significant LC-MS/MS bioanalysis experience looking to step up will also be considered.