Quality Assurance Specialist

Byondis is an independent Dutch biopharmaceutical company, based in Nijmegen, which focuses on developing innovative medicines in the fight against cancer and autoimmune diseases. We are very passionate to make hope of patients real by saving or improving their lives with new products that outperform current standards of care.

The Byondis CMC departments develop a range of manufacturing processes, starting with cell line generation and ending with aseptic filling of drug product. We have our own in-house GMP manufacturing facilities to produce monoclonal Antibodies (mAbs) and Antibody Drug Conjugates (ADCs). In addition, we use external contractors for certain GMP testing and drug product manufacture. The Quality Assurance (QA) department operates at the interface between science and compliance and ensures the safety of our products for application in first-in-human clinical studies.

Your Role

You will join our quality assurance team, committed to providing quality oversight and guidance to production and testing of clinical products, thereby advancing the innovative pipeline of Byondis. As a QA specialist you will combine technical knowledge of biotechnology-derived products with a thorough understanding of cGMP regulations. You will represent QA in CMC project teams, review and approve (technical) documents, give directions to change and deviation management and represent Byondis during inspections by Health Authorities. You will report to the head of the QA department.

What do you need to succeed in this role?

You need to have a technical background (preferably in the manufacturing and/or development of biotechnology- derived products), a demonstrated quality mindset and agility to work effectively in the dynamic environment of early product development. Since product knowledge is limited at the time of first-in-human studies, you need to be able to apply risk-based principles in a consistent manner across a wide range of topics. You need to collaborate effectively with your QA colleagues and interact with various scientific disciplines. Consequently, you must be a team player with good communication skills. Finally, you need to be result-oriented, proactive, creative and able to work with a high degree of ownership and independence.

• MSc degree in biotechnology or other relevant life science

• At least 5 years of experience in a biopharmaceutical development and/or manufacturing environment with good understanding of USP and DSP unit operations

• Demonstrated knowledge of cGMP standards within the biopharmaceutical industry

• Fluent in English and preferably in Dutch (written and spoken)

• Knowledge of aseptic processing (drug product manufacture) is preferred

• Experience in a QA role is preferred

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 pension scheme, 30 days annual holidays based on a fulltime position, and we organize several company events throughout the year.

Join Byondis and create the future you want, today.