Project Lead Quality

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.
Within the Byondis CMC department we develop our processes from cell line development up to Drug Product and we have our own in house GMP manufacturing facilities to produce monoclonal Antibodies (mAbs) and Antibody Drug Conjugates (ADCs) for our clinical needs.

Your Role

You will join our Operations team, connected by mutual respect and a deep-rooted commitment to manufacture and to secure and improve the quality of our innovative clinical products. Your responsibilities encompass a wide range of tasks, with main focus on leading the Operational Quality team, improving our documentation and training structure, and to support cGMP manufacture of (new) clinical products. To conduct your role effectively, you will have direct contact with other GMP departments like Quality Assurance, Quality Control, Engineering & Maintenance and IT. In addition, you will keep up on international regulations and GMP guidelines, represent Operations in project teams and participate in (internal) audits. You will also participate in the writing, reviewing and approval of GMP documentation (QAR, RAR, SOPs, etc.) as well as the handling of Changes and Deviations. You will report to the head of Operations.

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 flexible to act in a fast changing and demanding environment. You are result-oriented and use proactivity and creativity as your methodology to find solutions. You are self-motivated which enables you to work with a high degree of independence.

• A MSc degree in Biotechnology or other relevant life science field

• At least 10 years’ experience in a biopharmaceutical cGMP environment.

• In depth knowledge and experience in cGMP guidelines & regulations.

• Demonstrated experience in people management and leadership skills.

• An excellent quality mindset and eagerness to continuously improve processes.

• A can-do attitude, hands-on mentality embracing cross-functional collaboration.

• A flexible and pragmatic approach

• You have excellent social and communication skills in both Dutch and English.

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.

Contract hours: 32-40 hrs/week, preferably fulltime

If you are interested in joining Byondis in this challenging position, we welcome your application via the apply button.

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