Analytical Expert

Join Sobi’s Global CMC Science & Technology team as an Analytical Science & Technology (Analytics) Expert to lead analytical roles across projects and products, ensuring compliance, robustness, and continuous improvement of analytical methods in a remote European-based role.

Location: Remote (EU)

Responsibilities

• Act as Analytics SME taking overall responsibility for analytical methods and related work for specific products.
• Responsible for analytical method transfers, validations, and supporting product stability and shelf life through ongoing stability studies.
• Establishment and maintenance of reference materials and responsibility for product-specific method standards and qualified materials (critical reagents).
• Ensure lifecycle management, compliance, robustness, and relevance of analytical methods.
• Act as SME in regulatory filing, new launches, and ongoing supply of commercial products.
• Support investigations of deviations, changes, CAPAs, complaints, out-of-trends (OOT), and out-of-specifications (OOS).

Requirements

• MSc/PhD in analytical chemistry, chemistry, biochemistry, pharmacy, chemical engineering, or similar.
• +5 years of experience in the Life Science/Pharma industry with commercial products.
• Experience in analysis of biological drugs, validation, analytical tech transfer, stability studies, specifications, handling of reference standards and critical reagents.
• Skilled in common QC methods such as HPLC, spectroscopy, ELISA, bioassay.
• Experience working with contract manufacturers, CMOs, and CLOs.

Benefits

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