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 department has a job opening for an Officer that supports all ADQC analytical GMP operations and will be a member of a small and dedicated Release, Stability and Compliance team. Key responsibilities include the following:

• Management and distribution of analytical test samples
• Shipments of samples to external labs
• Supporting the analytical testing of the release of production batches and associated stability studies
• Management and distribution of reference standards
• Manage material specifications and release of these materials for the manufacturing of clinical materials
• Writing or updating (analytical) phase-appropriate GMP procedures (SOPs and WIs related to quality control)
• Supporting of our equipment (e.g. climate cabinets and freezers)
• Supporting GMP inspections and (internal) audits
• Reviewing and approving logbooks and reports
• Supervising training records of all ADQC co-workers performing GMP activities
• Point of contact for ADQC co-workers, QA (Quality Assurance), E&M (Engineering & maintenance) and OPS (Operations) in relation to daily (operational) questions on quality

WHAT DO YOU NEED TO SUCCEED IN THIS ROLE?

Ownership of activities, focusing 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; laboratory experience is preferred
• An excellent quality mindset, curious attitude and eagerness to continuously improve processes
• Experience with pharmaceutical IT applications, such as LIMS, is preferred
• Good knowledge of GMP regulations within the biopharmaceutical industry
• Good verbal and written skills in English
• Good communication skills, being proficient in Dutch is preferred
• A hands-on team player with a ‘can-do’ mentality