Associate Analytical Expert

Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.

As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.

We are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.

Job Description About the role Join Sobi’s Global CMC Science & Technology team and help shape how our medicines are developed and supplied worldwide. We are looking for an Associate Analytical Expert who will play a key role in ensuring the release of Sobi products by coordination of the stock of Critical Analytical Materials used for the release analyses at our Contract Laboratory Organisations (CLOs). By working cross-functionally with colleagues across Sobi and in close partnership with global contract laboratory organizations (CLOs), you will coordinate and monitor the use of Critical Analytical Materials to ensure continuous availability, re-supply, qualification and effective long-term planning.

In addition, you will be involved in the day-to-day analytical work supporting our products. You will have the opportunity to learn from experienced colleagues and gain insight into the business, supply, and lifecycle challenges across our portfolio. Over time, you will build a strong understanding of Sobi’s portfolio and contribute to the continued development of the analytical team.

This role can be performed remotely within the European time zone and reports to the Group Head of Analytics based at Sobi headquarters in Stockholm.

Key Responsibilities

• Secure continuous control of Critical Analytical Materials needed for release of Sobi products and “tracking” of the use of the stock of the materials. Examples are Reagents, Standards and Control samples.
• Continuously monitor the stock. Forecast demand, perform stock inventory, create supply plans, order materials, and update stock inventory of critical analytical materials.
• Ensure lifecycle management, compliance, and robustness of Critical Analytical Materials used in analytical methods at CLOs.
• Manage interactions with Sobi’s external partners to ensure continuous delivery of analytical data, protocols, and reports in relation to the Critical Analytical Material.
• Provide analytical expertise across product related activities.
• Contribute to analytical method transfers and support product stability and shelf-life activities through ongoing stability studies.
• Support investigations related to deviations, handling out-of-trend (OOT) and out-of-specification (OOS), as well as handling changes and CAPAs.
• Contribute to identifying, evaluating, and implementing improvements within the analytical team’s ways of working.

Qualifications Qualifications

• MSc or PhD in analytical chemistry, chemistry, biochemistry, pharmacy, chemical engineering, or related field.
• Experience of life sciences or pharmaceutical industry.
• Knowledge of common QC laboratory analytical methods, such as chromatography, spectroscopy, ELISA, and bioassays.
• Experience working with contract manufacturers and/or contract laboratories (CMOs/CLOs).
• Interest in automation, digital tools, and visualization of large data sets.
• Experience working in a GMP-regulated environment.
• Strong written and spoken English skills are required.

Additional Information How to apply We have an ongoing selection process in this recruitment and ask you to send yo