Analytical Expert

📋 Description

• Act as Analytics SME for analytical methods across the product in virtual plant teams
• Lead analytical method transfers, validations and stability studies support
• Establish and maintain reference materials and qualified reagents
• Ensure lifecycle, compliance, robustness, and relevance of analytical methods
• Serve as SME for regulatory filings, launches and supply of commercial products
• Support investigations of deviations, changes, CAPAs, complaints, OOT and OOS

🎯 Requirements

• MSc/PhD in analytical chemistry, chemistry, biochemistry, pharmacy or chemical engineering
• 5+ years in Life Science/Pharma with commercial products
• Experience with biological drugs analysis, validation, tech transfer, stability, and reference standards
• Skilled in QC methods: HPLC, spectroscopy, ELISA or bioassay
• Experience working with CMOs and CLOs

🎁 Benefits

• Collaborative and team-oriented environment
• Opportunities for professional growth
• Diversity and Inclusion
• Making a positive impact for ultra-rare disease patients
• Emphasis on work/life balance