Scientific Laboratory Lead
3 days ago
**Senior Process Development Scientist Role Overview**
We are currently recruiting for an exciting opportunity with a leading Pharmaceutical organization based in Dublin. This is an excellent position for individuals looking to join a multinational company that excels in its field.
The role involves working on-site in a laboratory setting, providing analytical support activities including:
- Analytical Method Troubleshooting
- Analytical Method Lifecycle (Development, Qualification, Validation, Remediation)
- Analytical support for Process Development and Qualification activities at the site and wider network
Key Responsibilities:
- Performing analytical method troubleshooting, qualification, validation, bridging, and transfer
- Providing analytical support for Process Development and Process Qualification activities
- Serving as a support for the Attribute Sciences function on cross-functional teams/programs
Documentation Requirements:
- Timely documentation of Analytical data in the electronic notebook system
- Understanding of data flow in laboratory systems and data integrity
Team Collaboration:
- Participate in the peer review of analytical data
- Compliance with Standard Operating Procedures for the Attribute Sciences Laboratory
Quality Assurance:
- Ensure the laboratory is operated in a safe and environmentally friendly manner
- Ensure ongoing compliance with phase-appropriate GMP, including compliance within the LMS training system
Additional Responsibilities:
- Ensuring high levels of Laboratory housekeeping, including inventory control of samples and consumables
- Timely completion of Laboratory Investigations, Deviations, PMAFs
- Participating in internal/external audits/inspections as required
Requirements and Qualifications:
- Bachelor's degree in Analytical Chemistry/Biochemistry or related discipline
- 3-6 years of relevant analytical experience in the Pharmaceutical Industry
- Subject Matter Expertise in General and Compendial methods used in the analysis of Drug Product
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