COLMAN BYRNE

Colman Byrne
Director, Analytical Research & Development

Over twenty five years of experience in analytical release and stability testing, method development and validation (QC), API manufacturing and cleaning validation for small molecule, peptide and protein products, including:

• Coordinating and evaluating stability studies on various pharmaceutical dosage forms
• Direction of method development and validation, analytical testing and cleaning validation studies for small molecule, protein and peptide products
• Coordination of bioanalytical testing and method validation studies for pre-clinical & Phase I-III clinical programs
• Direction of process development and pilot scale API manufacturing activities, including API and drug product batch record review
• Performance of analytical data, regulatory submission and site audits of contract pharmaceutical and bioanalytical labs, drug product and API manufacturers
• Writing SOPs, analytical methods, stability and validation protocols and reports for API, drug product, raw and reference materials

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