Analytical Expert

Position

Vollzeit

Senior

Wissenschaft & Forschung

Konditionen

Remote

Endet in 30 Tagen

Anforderungen

5+ J. Erfahrung

Master

EU/EFTA-Bewilligung

Beschreibung

Join Sobi’s Global CMC Science & Technology team and help shape how our medicines are developed and supplied worldwide. We’re hiring an Analytical Science & Technology (Analytics) Expert who will take a leading analytical role across our project and product portfolio. Working cross-functionally with colleagues throughout Sobi—and in close partnership with external contract manufacturing organizations (CMOs) globally—you’ll ensure our analytical methods remain compliant, robust, and fit for purpose, while also driving method transfers, validations, and continuous improvements. You’ll coordinate stability studies and support investigations and quality activities (deviations, changes, and CAPAs), acting as an Analytical Subject Matter Expert (SME) to help deliver reliable products to patients. This is a remote role located within the European time zone, reporting to Group Head Analytics based in Sobi HQ, Stockholm.

Aufgaben

Act as Analytics SME taking overall responsibility for analytical methods and analytical related work for the specific product.
Responsible for analytical method transfers, validations as well as 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.
Ensure life cycle management, compliance, robustness, and relevance of analytical methods.
Act as SME in work with regulatory filing, new launches as well as the ongoing work with supply of the commercial products.
Support investigations of deviations, changes and CAPAs, complaints, out of trends (OOT) and out of specifications (OOS).

Anforderungen

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.

Technologien

HPLCspectroscopyELISAbioassay

Vorteile

Collaborative and team-oriented environment.
Opportunities for professional growth.
Diversity and Inclusion.
Competitive compensation for your work.
Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments.
Emphasis on work/life balance.

Unternehmen

sobi

Biopharmaceuticals

Sobi is a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. We are a specialised international biopharmaceutical company transforming the lives of people with rare and debilitating diseases, providing reliable access to innovative medicines in the areas of haematology, immunology, and specialty care. Sobi’s share is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.