Release and Stability Coordination Officer

Byondis is an independent Dutch biopharmaceutical company, based in Nijmegen, that focuses on developing innovative medicines against cancer and autoimmune diseases. We are driven by one goal: to develop new treatments to improve the standard of care for patients.

Your Role

The department of Analytical Development and Quality Control (ADQC) plays a key role in Byondis’ development and manufacturing because without extensive and accurate measurements, biotechnology-derived medicinal products cannot be designed, improved or applied. That is why we take pride in providing high quality analytical information to ensure the safety and efficacy of our innovative products in patients.

ADQC is responsible for all analytical testing to enable the development, manufacture and use of biotherapeutic products for toxicological assessments and clinical trials. The department develops, qualifies and applies a broad panel of analytical methods to characterize new biological entities such as monoclonal antibodies and antibody drug conjugates. These methods are also used to support the development of manufacturing processes and to perform quality control testing under GMP conditions.

The department comprises a diverse and multidisciplinary team of about 45 people with in-depth knowledge and experience in various analytical areas. We always seek collaboration and we are determined to provide answers rather than test results.

The ADQC department has a job opening for a Release and Stability Officer. This officer supports all ADQC release and stability operations and will be a member of a departmental Release, Stability and Compliance team. Key responsibilities include the following:

• Coordinating the analytical testing in support of the release of production batches and associated stability studies
• Management and distribution of analytical test samples
• Shipments of samples to external labs
• Writing and review of stability study protocols, reports and other GMP documentation
• Management of reference standards.
• Writing or updating (analytical) phase-appropriate GMP procedures (SOPs and WIs related to quality control)
• Coordination of the maintenance of our equipment (climate cabinets and freezers)
• Review of FMS trending reports
• Supporting GMP inspections and (internal) audits

What do you need to succeed in this role?

Ownership of activities with a mindset on precision and quality of your own, and your colleague's, work. A natural team player with an attitude to collaborate and communicate, as well as being open-minded and flexible to act in a fast changing and demanding environment. You are result-oriented and use proactivity and creativity to find solutions. You are self-motivated, which enables you to work with a high degree of independence.

• A B.Sc. level of education (or equivalent based on working experience)
• At least 1 - 3 years of GMP experience in the biopharmaceutical industry
• An excellent quality mindset, curious attitude and eagerness to continuously improve processes
• Good knowledge of GMP regulations within the biopharmaceutical industry
• Experience and/or affinity with maintaining equipment, such as climate cabinets and freezers
• Experience with pharmaceutical IT applications, such as LIMS, is a strong preference
• Experience with project management is a strong preference
• A can-do attitude, hands-on mentality embracing cross-functional collaboration
• Good verbal and written skills in English
• Excellent communication skills
• Team player

Benefits and well being

Besides a competitive salary, we offer you a dynamic working environment at our state-of-the-art campus in Nijmegen.  Our values as integrity, authenticity, entrepreneurship, quality and trust are very highly regarded. We also offer a good pension scheme, 30 days annual holidays based on a full-time position and we organize several company events throughout the year.

Join Byondis and create the future you want, today

Contract hours: 32/40 hrs./week
Salary: depending on experience
Location: Nijmegen

Applicants must be nationals of a Member State of the European Union or hold a valid work permit for the European Union.

For further information, please contact Human Resources, at tel. +31 (0)24 679 5100 or by email; recruitment@byondis.com. If you are interested in joining Byondis in this challenging position, we welcome your application via the apply button. Please send your application before May 18 ^th , 2025.