Analytical Expert
SobiJob Description
📋 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