Analytical Science & Technology Technical Lead

Analytical Science & Technology Technical Lead

Sobi

Stockholm, Sweden

About the role

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) Specialists 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.

Key Responsibilities

• 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;
• 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 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;
• Experience of GMP;
• English is required and Chinese highly preferred.