Analytical Expert

📋 Description

• Act as Analytics SME for analytical methods and related work on products.
• Lead method transfers, validations, and support stability studies.
• Establish/maintain reference materials and product-specific method standards.
• Ensure lifecycle management and compliance of analytical methods.
• Serve as SME for regulatory filings, launches, and product supply.
• Support investigations of deviations, CAPAs, OOT, and OOS.

🎯 Requirements

• MSc/PhD in analytical chemistry, chemistry, biochemistry, pharmacy, or related.
• 5+ years in Life Science/Pharma with commercial products.
• Experience in biological drug analysis, validation, tech transfer, stability studies, specs, reference standards.
• Skilled in QC methods (HPLC, spectroscopy, ELISA, bioassay).
• Experience with CMOs/CLOs (contract manufacturers).

🎁 Benefits

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