Materials Quality Consultant (contractor) - Leiden, NL
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines, we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.
For our Cell Therapy organization in Leiden/NL, we are looking for a Materials Quality Consultant (contractor) for 6 months.
Scope of the job
We are seeking a highly skilled and experienced Materials Quality Consultant to support our organization in transitioning from an Incoming Goods process suitable for Phase I/II Clinical to a process suitable for Phase III/Commercial. The consultant will play a crucial role in drafting a risk assessment for QC and MFG materials, defining Full vs Reduced testing requirements, coordinating Material Qualifications, identifying suitable contract testing labs, coordinating with the development team for in-house analytical development, and supporting QC management in implementing a revised incoming goods strategy.
- Draft a comprehensive risk assessment for QC and MFG materials, considering guidelines and regulations relevant to the quality of materials used in manufacturing and quality control settings.
- Define Full vs Reduced testing requirements for materials based on Phase III/Commercial needs, ensuring compliance with industry standards and regulations.
- Coordinate the qualification process for materials, ensuring appropriate testing, documentation, and compliance with relevant guidelines.
- Identify and evaluate suitable contract testing labs for specific testing activities, considering quality, reliability, and cost-effectiveness.
- Collaborate with the development team to establish in-house analytical development processes, methodologies, and equipment necessary for quality control.
- Assist QC management in the implementation of a revised incoming goods strategy, ensuring seamless integration of new processes and practices.
- Stay updated with industry trends, regulations, and best practices related to materials quality in manufacturing and quality control settings.
Who are you?
- Proven experience as a Materials Quality Consultant or in a similar role, with a strong focus on quality control and manufacturing processes.
- In-depth knowledge of guidelines and regulations pertaining to the quality of materials used in manufacturing and quality control settings.
- Proficient in writing comprehensive risk assessments and implementing risk mitigation strategies.
- Familiarity with Full vs Reduced testing requirements and the ability to define appropriate testing strategies based on project needs.
- Experience in coordinating material qualifications and ensuring compliance with relevant guidelines and standards.
- Strong analytical and problem-solving skills with the ability to identify and resolve quality-related issues effectively.
- Excellent communication and coordination skills to collaborate with cross-functional teams and external stakeholders.
- Nice to have: Experience in a Cell & Gene therapy setting, understanding the unique challenges and requirements of this field.
- Minimum 6-month contract with the possibility of extension based on project needs.
- Ideally, 4-5 days per week availability; however, exceptional candidates with 3-days per week availability will be considered.
- Start date: As soon as possible, preferably in July.
If you possess the necessary expertise and experience in materials quality, risk assessment, and manufacturing processes, and you are passionate about contributing to the growth and success of our organization, we invite you to apply for this position.
What’s in it for you?
You will be part of a fast growing and amazing company. As a ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research.
We are Galapagos : together we can make it happen…!