Analytical Science

3 weeks ago

Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
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 transforms 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

Sobi is now recruiting for an exciting position as Analytical Science & Technology (AS&T) Specialist in our Global CMC Science & Technology Team. In this role, you will be responsible for our project and product portfolio from an analytical standpoint. The role includes cross-functional work within Sobi and with our external contract manufacturing organizations (CMOs) in a global context. AS&T ensures compliance and relevance of both established and newly developed analytical methods, is responsible for analytical method transfers and validations, and is responsible for continuous method verification and implementation of new technologies and improvements in the analytical field. AS&T is also responsible for coordination of stability studies, handling of deviations, changes, and CAPAs. In the role, you will work as Analytical Subject Matter Experts (SME).

Key Responsibilities
  • Be able to act as AS&T product responsible taking overall responsibility for analytical methods and analytical related work for the specific product in the product teams
  • 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)
  • Responsible for analytical method transfers as well as supporting product stability and shelf life through ongoing stability studies
Qualifications
  • MSc/PhD, analytical chemistry/chemistry/biochemistry/pharmacist/chemical engineering or similar
  • +3 years of experience in Life Science/Pharma industry
  • Experience in analysis of biological drugs and/or small molecule drugs, validation, analytical tech transfer, stability studies, specifications
  • Skilled in performing common QC methods in the laboratory, e.g. any of HPLC, spectroscopy, ELISA, bioassay
  • Experience of working with contract manufacturers with CMOs and CLOs
  • Experience of GMP
  • English and Swedish
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 1,800 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, we're ready to take on the world's diseases, ailments, and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're 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 can't 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.
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