Analytical Method Development & Validation Scientist

Uniting Holding; Loughrea; On-site; EUR 65,000 - 90,000; Full time

Job summary

Chanelle Pharma is seeking an experienced Method Development & Validation Analyst to join its R&D Medical team in Ireland. You will own SIM development, validation studies, and nitrosamine impurity testing, ensuring compliance with ICH Q2(R2) and regulatory expectations.

This hands-on role requires strong chromatographic expertise, data integrity, and the ability to troubleshoot challenging analyses. You will lead method development for pipeline products, perform forced degradation studies,

Qualifications

• Bachelor's degree in Analytical Chemistry or related life science field.
• 5+ years in analytical method development, validation, or QC in GMP pharma/CRO.
• Proven HPLC/UPLC method development and troubleshooting.
• Nitrosamine testing method development experience.
• LC-MS or advanced chromatographic techniques experience.
• Experience with method transfer and regulatory submissions.
• Knowledge of stability testing under ICH guidelines.
• Familiarity with Empower or LIMS and data integrity principles.

Responsibilities

• Lead or co-lead SIM method development for pipeline products.
• Perform method validation per ICH Q2(R2) and write validation reports.
• Develop nitrosamine impurity test methods per ICH M7 and regulatory expectations.
• Troubleshoot chromatographic issues to meet robustness targets.
• Document methods, SOPs, and transfer to QA/Production as needed.
• Support audits and regulatory inspections related to analytical methods.
• Mentor junior staff on method development and data integrity.

Skills

HPLC/UPLC method development

Analytical method validation

Troubleshooting

Data integrity

Team mentoring

Education

Bachelor's degree in Analytical Chemistry or related life science

Tools

Empower

LIMS

GC

LC-MS

Thermal analysis

Job description

Chanelle Pharma is seeking an experienced Method Development & Validation Analyst to join its R&D Medical team in Ireland. You will own SIM development, validation studies, and nitrosamine impurity testing, ensuring compliance with ICH Q2(R2) and regulatory expectations.

This hands-on role requires strong chromatographic expertise, data integrity, and the ability to troubleshoot challenging analyses. You will lead method development for pipeline products, perform forced degradation studies,