About This Role
This analytical scientist role focuses on critical process parameters and product quality attributes, driving analytical development and life cycle management projects. The position involves daily execution, project reporting, continuous improvement, and collaboration with various internal teams and sister sites. It suits a specialist ready to contribute to a global network in manufacturing and supply.
Responsibilities
- Act as a specialist in critical process parameters and product quality attributes
- Serve as a key team member for analytical development and analytical/product Life Cycle Management projects
- Work closely with Autonomous Production Units (APUs) to support analytical LCM execution activities on a daily/weekly basis
- Report on assigned analytical projects' progress and identify opportunities to improve site performance
- Work closely with all functions, including MSAT, Quality, Operations, Validation, Regulatory, and program leads on assigned projects
- Interact with sister sites through various projects/product forums
- Support boosters for CI improvements in MSAT-Analytical and QC as required
Requirements
- Degree in Biologics or Chemistry (NFQ Level 7 or 8) or a related scientific discipline
- Knowledge of lyophilisation (Lyo) and mAbs sterile fill/finish context
- Experience leading analytical development projects (research, design, implementation, and transfer/qualification/validation), applying design for manufacture principles
- Experience developing and implementing analytical control strategies
- Experience leading analytical qualification and validation activities
- Experience providing technical support, troubleshooting and investigation to support manufacturing and GMP activities
- Subject Matter Expert (SME) in analytical quality attributes and critical process parameters
- Experience leading analytical transfer projects
- Experience supporting experimental programmes, including pilot plant operations and studies
- Experience designing, executing and implementing analytical development programmes
- Experience working as a resource for MSAT Analytical team on analytical development and product Life Cycle Management projects
Benefits
- Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply
- Transform lives worldwide by delivering life-changing treatments anywhere, anytime
- Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day, with pride
- Help deliver 30+ new product launches by 2030, ensuring patients get treatments faster than ever
