Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Thermo Fisher Scientific Inc. invites you to be an Analytical Development Analyst, playing a key role in modern research in Ireland, advancing scientific discoveries.
Responsibilities
* Liaise with customers and internal teams (Process Development Services, Quality, Operations) to strictly establish timelines for priority analysis, ensuring customer needs and objectives are flawlessly met.
* Develop and optimize new or existing analytical methods.
* Participate in method validation, including method equivalency and periodic reviews.
* Manage change controls for analytical and instrument modifications.
New Product Technology Transfer
* Attend cross-functional and analytical technology transfer meetings.
* Determine method/equipment requirements, facilitate procurement, and coordinate installation.
* Conduct paper and bench evaluations of key analytical methods.
* Document and verify training, develop/update analytical methods and specifications.
* Perform gap analysis and acquire necessary documents/data from client sites.
* Prepare/review validation documentation for new laboratory equipment installation.
* Provide technical support to Quality Labs during validation campaigns and stability testing.
Testing Activities
* Perform and review AD sample testing, including non-routine and development samples.
* Issue reports on quality issues, support tiered review meetings, and prepare for inspections.
* Troubleshoot laboratory equipment, liaise with service engineers, and approve post-repair documentation.
Laboratory GMP Compliance
* Acquire knowledge of relevant SOPs, maintain laboratory notebooks, and perform equipment calibration.
* Ensure validation/calibration documentation is signed off before use.
* Maintain housekeeping standards, participate in audits, and complete assigned actions promptly.
Technical Support or Troubleshooting for Existing Products
* Provide technical data/opinion to internal and external customers.
* Participate in deviation investigations and regulatory meetings.
* Support quality issues with dedicated analytical resources and communicate findings.
Environmental Health & Safety (EHS) Responsibilities
* Perform duties in compliance with SOPs, EHS standards, and legal requirements.
* Report accidents, incidents, or EHS issues promptly.
* Maintain a clean and safe work area.
Quality Responsibilities
* Adhere to our Quality Management System requirements and participate in quality initiatives.
* Maintain GMP standards and be inspection-ready at all times.
Education and Experience
* Bachelor's Degree in Chemistry or Analytical Chemistry (Master's preferred).
* At least 2 years of relevant experience.
* Up-to-date knowledge of Quality guidelines (e.g., ICH, FDA, IMB, QMS, GMP).
* Experience with project planning, management, and running QIPs.
Interpersonal Skills
* Excellent communication and facilitation skills.
* Demonstrated ability to lead technical projects effectively.
* Leadership, influencing, and negotiating skills.
* A positive, can-do approach to work and the ability to mentor others.
Join us to make a remarkable impact in the scientific community and successfully implement innovative solutions