Key Skills

Job Description

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 Are you a Quality Assurance professional who wants to work in collaborative team in which you can grow and develop your skills ?You will join our quality assurance team, committed to providing quality oversight and guidance to our production of clinical supplies, advancing the progress of Byondis. The specialist role will support information technology and engineering departments, applying knowledge across these fields and the requirements for cGMP and GAMP in an effective and efficient fashion to assure compliance. Wider support in compliance and oversight tasks may also include providing guidance on regulations and GMP, performing risk assessments, support qualification of IT systems, equipment and utilities, representing QA in project teams, documentation review and approval, support for event and change management, and participation in (internal) audits. You will report to the head of the QA department What do you need to succeed in this role A quality mindset and the capacity to apply this in a dynamic environment for First in Human and subsequent clinical GMP productions. The ability to apply risk based principles in a consistent manner across a wide range of topics. A team player taking responsibility for their own work ensuring team goals are met. Enthusiasm and good collaboration and communication skills. You are result-oriented, proactive, and creative. You are self-motivated which enables you to work with a high degree of independence. MSc degree in Biotechnology or other relevant life science or engineering field At least 5 years’ experience in a biopharmaceutical GMP environment with a relation to IT and/or equipment qualification. Operational experience in GMP validation, engineering or IT is an advantage In depth knowledge of cGMP standards within the biopharmaceutical industry towards operational processes with a focus on early clinical activities Skills in Lean/Six Sigma and/or GAMP5 v2 approaches are an advantage A can-do attitude, hands-on mentality You have excellent social skills, good communication in English and preferably Dutch, and welcome cross-functional collaboration Able to identify opportunities for improvements in efficiency and effectiveness of quality 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 Contract hours: 32-40 hrs/week, preferably full time Applicants must be nationals of a Member State of the European Union or hold a valid work permit for the European Union

Core Responsibilities

Provide quality oversight and guidance for clinical-supply production, with a focus on supporting IT and engineering departments and ensuring cGMP and GAMP compliance. Support risk assessments, qualification activities, project teams, documentation review and approval, event and change management, and internal audits.

Requirements

Requires an MSc in biotechnology or another relevant life science or engineering field, plus at least five years of experience in a biopharmaceutical GMP environment related to IT and/or equipment qualification. Candidates should have in-depth knowledge of cGMP, a quality-focused and risk-based approach, and strong collaboration and communication skills; operational GMP validation, engineering, or IT experience and Lean/Six Sigma or GAMP5 v2 knowledge are advantages.

Benefits

• Pension Scheme
• 30 Days of Annual Leave
• Company Events