Analytical Science & Technology Technical Lead

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. This is a remote role located within the European time zone, reporting to Group Head Analytics based in Sobi HQ, Stockholm.

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)

Requirements

• 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.
• How to apply
• We have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume.
• Why Join Us?
• Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
• 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
• We know our employees are our most valuable asset and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.
• Sobi Culture
• At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

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