Analytical Expert
Remote
Job Summary
Lead analytical methods and related work for specific products within virtual plant teams, ensuring compliance, robustness, and relevance across the project and product portfolio. Manage analytical method transfers, validations, and ongoing stability studies to support product shelf life. Establish and maintain reference materials, method standards, and qualified critical reagents. Act as a Subject Matter Expert for regulatory filings, new launches, and commercial product supply. Coordinate investigations for deviations, changes, CAPAs, complaints, out-of-trend, and out-of-specification results. Partner with global contract manufacturing organizations to ensure reliable product delivery. This remote role reports to the Group Head Analytics in Stockholm, with a focus on transforming care for rare disease patients.
Required Qualifications
- MSc/PhD, analytical chemistry/chemistry/biochemistry/pharmacist/chemical engineering or similar
- +5 years of experience of Life Science/Pharma industry with commercial products
- Experience of analysis of biological drugs, validation, analytical tech transfer, stability studies, specifications, handling of reference standards and critical reagents
- Skilled in common QC methods in the laboratory, e.g. any of HPLC, spectroscopy, ELISA, bioassay
- Experience of working with contract manufacturer with CMOs and CLOs
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