About the role
Join Sobi鈥檚 Global CMC Science & Technology team and help shape how our medicines are developed and supplied worldwide. We鈥檙e hiring an Analytical Science & Technology (Analytics) Specialists who will take a leading analytical role across our project and product portfolio. Working cross-functionally with colleagues throughout Sobi鈥攁nd in close partnership with external contract manufacturing organizations (CMOs) globally鈥攜ou鈥檒l ensure our analytical methods remain compliant, robust, and fit for purpose, while also driving method transfers, validations, and continuous improvements. You鈥檒l 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聽Group Head Analytics based in Sobi HQ, Stockholm.
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Key Responsibilities
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Be able to act as Analytics product responsible taking overall responsibility for analytical methods and analytical related work for the specific product in e.g. the virtual plant teams
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Responsible for analytical method transfers, validations as well as supporting product stability and shelf life through ongoing stability studies
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Establishment and maintenance of reference materials and responsibility for product specific method standards and qualified materials (critical reagents)
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Ensure life cycle management, compliance, robustness, and relevance of analytical methods
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Act as SME in work with regulatory filing, new launches as well as the ongoing work with supply of the commercial products
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Support investigations of deviations, changes and CAPAs, complaints, out of trends (OOT) and out of specifications (OOS)