Remote Analytics Expert – Pharma Method Transfer

Sobi; Stockholms kommun; On-site; SEK 992,501 - 1,433,612; Full time

Benefits offered by this job

Remote work across Europe

Job summary

Sobi is seeking an Analytical Science & Technology (Analytics) Expert to drive analytical planning and execution across our product portfolio. You will collaborate with internal teams and external CMOs to ensure compliant, robust analytical methods and lead method transfers and validations.

Reporting to the Group Head of Analytics at Sobi HQ in Stockholm, you will support stability studies and lifecycle management while contributing to regulatory filings and product launches across a European

Qualifications

• MSc/PhD in analytical chemistry or related field.
• +5 years in Life Science/Pharma with commercial products.
• Strong expertise in analytical methods, validation, tech transfer, stability and reference standards.
• Experience with CMOs/CLOs and regulatory filings.

Responsibilities

• Act as Analytics SME and take responsibility for analytical methods for specific products.
• Lead method transfers and validations; support stability studies.
• Manage reference materials and qualified reagents; ensure method standards.
• Ensure lifecycle management, compliance and robustness of analytical methods.
• Serve as SME for regulatory filings, launches and supply.
• Assist investigations of deviations, CAPAs and out-of-specifications.

Skills

Analytical method development

Regulatory filings

Cross-functional collaboration

CMO/CLO liaison

Quality control techniques

Education

MSc/PhD in analytical chemistry

Job description

Sobi is seeking an Analytical Science & Technology (Analytics) Expert to drive analytical planning and execution across our product portfolio. You will collaborate with internal teams and external CMOs to ensure compliant, robust analytical methods and lead method transfers and validations.

Reporting to the Group Head of Analytics at Sobi HQ in Stockholm, you will support stability studies and lifecycle management while contributing to regulatory filings and product launches across a European