Analytical Science & Technology Technical Lead

About the role

Join Sobis Global CMC Science & Technology team and help shape how our medicines are developed and supplied worldwide. Were 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 Sobiand in close partnership with external contract manufacturing organizations (CMOs) globallyyoull ensure our analytical methods remain compliant robust and fit for purpose while also driving method transfers validations and continuous improvements. Youll 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

• 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 :

• 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. 

Additional Information :

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 in English. 

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:

• Emphasis on work/life balance
• 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

We are a global company with over 1900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins and a Board with a stellar track record were ready to take on the worlds diseases ailments and adversity. Our people believe they have the power to make a positive impact in others lives because thats exactly what we do here. If youre seeking a career that taps into your talents in a way that makes the world a better healthier place we just may have a job for you.

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.

As a specialized biopharmaceutical company we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one but we know we cant change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients partners and stakeholders across the entire value chain. Together we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

Remote Work :

Yes

Employment Type :

Full-time