Analytical Expert

Sobi seeks an Analytical Expert in Basel (remote) to lead analytical methods and compliance for biopharmaceutical products, supporting global development and supply.

The company is looking for an Analytical Subject Matter Expert to join its Global CMC Science & Technology team. This position focuses on ensuring the reliability of medicines through robust analytical strategies, supporting the worldwide development and supply of products for patients. The role operates remotely within European time zones and reports to the Group Head Analytics in Stockholm.

Responsibilities

• Serve as the primary expert for analytical methods, overseeing all related activities for designated products.
• Manage method transfers and validations while supporting product stability and shelf-life assessments through continuous studies.
• Create and maintain reference materials, ensuring product-specific standards and qualified critical reagents are properly handled.
• Oversee the lifecycle management of analytical methods to guarantee compliance, robustness, and ongoing relevance.
• Provide expert guidance during regulatory submissions, new product launches, and commercial supply operations.
• Lead investigations into deviations, changes, CAPAs, complaints, out-of-trend results, and out-of-specification findings.

Requirements

• Hold an MSc or PhD in analytical chemistry, chemistry, biochemistry, pharmacy, chemical engineering, or a closely related field.
• Possess at least five years of experience in the life science or pharmaceutical industry with commercial products.
• Demonstrate expertise in analyzing biological drugs, including validation, analytical technology transfer, stability studies, specifications, and handling of reference standards and critical reagents.
• Be proficient in common laboratory quality control methods such as HPLC, spectroscopy, ELISA, or bioassay.
• Have experience collaborating with contract manufacturers, including CMOs and CLOs.

What the company offers

• Work in a collaborative and team-oriented environment.
• Access opportunities for professional growth and development.
• Be part of a culture that values diversity and inclusion.
• Receive competitive compensation for your contributions.
• Make a positive impact by helping ultra-rare disease patients who need life-saving treatments.
• Enjoy an emphasis on work/life balance.
• Benefit from a competitive package supporting health and happiness.

About the company

Sobi is a specialized international biopharmaceutical company dedicated to transforming the lives of people with rare and debilitating diseases. The organization refuses to accept the status quo, striving to find new ways to help those affected by rare diseases. The team is diverse, entrepreneurial, and passionate about growth, challenging the status quo to redefine standards of care. Sobi is committed to an inclusive, sustainable, and flexible workplace that fosters growth and development.

• Encourages candidates to apply even if they do not meet 100% of the qualifications.
• The work redefines the standards of care and transforms the lives of people living with rare diseases.
• The team is diverse, entrepreneurial, passionate about growth, and challenges the status quo.
• Committed to an inclusive, sustainable and flexible workplace that fosters growth and development.
• Sobi refuses to accept the status quo and is dedicated to finding new ways of helping those affected by rare diseases.
• Sobi is a specialized international biopharmaceutical company transforming the lives of people with rare and debilitating diseases.

How to apply

Documents to submit:

• resume