Eurofins BioPharma Product Testing Toronto, Inc. is seeking a detail-oriented and analytical Analyst II R&D to join our Research and Development team in Toronto, Canada. In this role, you will support the development and validation of analytical methods for pharmaceutical products, ensuring quality, safety, and regulatory compliance. You will work collaboratively with cross-functional teams to conduct testing, analyze data, and contribute to the advancement of our product portfolio.
Key Responsibilities:
Develop, validate, verify, and transfer analytical methods for assay and impurities testing in accordance with ICH and regulatory guidelines.
Perform routine and validation analysis using advanced analytical instrumentation including HPLC, GC, LC-MS/MS, and GC-MS/MS.
Conduct analytical testing and quality control procedures on pharmaceutical products using appropriate laboratory techniques.
Analyze and interpret complex analytical data, ensuring accuracy, completeness, and compliance with documentation standards.
Prepare and review method validation/verification/transfer protocols and final reports with precision and clarity.
Troubleshoot analytical methods and resolve technical issues to ensure consistent and reliable results.
Support and conduct OOS/OOT investigations and assist in identifying root causes and corrective actions.
Coordinate method transfer studies between clients and internal departments to ensure successful implementation and reproducibility of methods.
Maintain accurate and organized laboratory records, ensuring full traceability and compliance with regulatory requirements.
Review technical documents, data packages, and proposals as required.
Collaborate with R&D scientists, Quality Assurance, and project managers to support product development initiatives.
Assist with SOP training for new personnel and support SOP revisions as needed.
Liaise with clients to maintain strong professional relationships and provide technical support.
Provide ongoing technical guidance and training to staff to strengthen departmental capabilities.
Stay current with emerging technologies, industry best practices, and regulatory updates relevant to pharmaceutical testing.
Support the R&D Manager in departmental operations to ensure smooth workflow and achievement of business goals.
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