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Analytical Methods Specialist
2 weeks ago
Quality Assurance Laboratory Leadership Opportunity
We are seeking a highly experienced laboratory professional to lead our In-Process Control (IPC) laboratory team in Dublin.
About the Role
- Lead analytical method transfers for IPC testing, ensuring timely completion and adherence to project objectives.
- Coordinate technical transfer activities, collaborating with internal teams, manufacturing sites, and external partners.
- Develop and validate IPC analytical methods, including protocol design, execution, and documentation.
- Conduct risk assessments and troubleshooting to address technical challenges and ensure successful implementation of analytical methods.
- Generate and review technical documents, such as IPC transfer protocols, reports, and standard operating procedures (SOPs).
Requirements
- Bachelor's degree or equivalent in Biological Sciences, Chemistry, or other biotechnical science.
- Minimum 10 years of laboratory experience in a GMP environment.
- 5 years of analytical instrument validation/qualification experience preferred.
- Proven leadership experience in a GMP laboratory.
- In-depth understanding of current regulatory requirements for IPC or QC, including analytical testing, data integrity, and cGMP laboratory equipment validation.
