Sobi

• Provide strategic leadership and operational oversight to ensure the successful, on-time, and high-quality launch of Sobi's launches in future pipeline products • Establish and lead Sobi's Launch Excellence framework, integrating cross-functional planning, governance, and performance measurement • Serve as the central orchestrator of launch readiness, ensuring alignment across Commercial, Medical Affairs, Market Access, Regulatory Affairs, Supply Chain, and other key functions • Embed a culture of operational excellence, accountability, and continuous improvement • Leverage data-driven insights and market intelligence to optimize launch performance and patient impact in rare disease markets • Define and lead the North America Launch Excellence strategy • Establish and evolve a repeatable launch framework that drives consistency, accountability, and excellence across all product launches • Oversee the end-to-end launch planning and execution process, setting clear milestones, timelines, and deliverables • Partner with global and regional leadership to ensure launch readiness governance, including stage gates, KPIs, and risk management processes • Lead a high-performing, cross-functional launch team including representatives from Marketing, Sales, Medical Affairs, Market Access, Customer Experience, Insights and Operations, Supply Chain, and Regulatory Affairs

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

• Support monitoring activities (data collection) • Support monitoring CAPAs • Support transfer of value reporting • Manage annual FMV updates • Preparation, communication and monitoring of Data Privacy Notice (DPN) • Support compliance trainings (systems) • Support with systems by being a super user (e.g. Veeva, SOOS) • Supporting Compliance Director and Senior Compliance Manager with various tasks

Role Description 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. Key Responsibilities - Act as Analytics SME taking overall responsibility for analytical methods and analytical related work for the specific product in e.g. the virtual plant teams. - 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 (critical reagents). - 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). Qualifications - MSc/PhD, analytical chemistry/chemistry/biochemistry/pharmacist/chemical engineering or similar. - +5 years of experience in 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 manufacturers with CMOs and CLOs. Benefits - 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.