Senior Analytical Quality Control Specialist (Large Molecules)

Join Our Team as a Senior Analytical Quality Control Specialist (Large Molecules)

Welcome to our team

Our Global Science & Technology (S&T) division provides technical expertise to our animal health manufacturing organizations, leveraging science, technology and innovation to ensure new product commercialization and supply continuity. It continuously improves processes and analytics to meet customer demands through manufacturing excellence. A new Global Analytical Technical Services (ATS) team, covering Small and Large Molecules, is established to oversee analytical activities across the Animal Health network. The ATS-Bio Inline Support EU team (7 employees) provides essential support to the Animal Health Quality Control (QC) laboratories across Europe. They focus on conducting technical investigations, performing data analysis, troubleshooting, and improving bio-analytical tests. Additionally, they coordinate method transfer and validation and compliance activities and develop and implement new technologies and testing methodologies.

Purpose of the role

Reporting to the Manager Bio Inline Support EU (Analytical Technical Services), you will be responsible for enhancing the efficiency and reliability of biological quality control assays for large molecules, ensuring compliance with regulatory standards across multiple laboratories in Europe. By leading investigations, method transfers, and remediation programs, you will contribute to unconstrained supply of our products, global harmonization of QC practices and the successful transfer of biomaterials and tests. Additionally, the role will foster knowledge sharing and skill development among team members and QC sites, ultimately driving continuous improvement in analytical processes and outcomes. This role requires close collaboration with a diverse range of stakeholders throughout the organization (e.g., Quality Control, Quality Assurance, R&D, Regulatory Affairs, Science & Technology).

Main tasks and responsibilities

• Supporting or leading ad-hoc global and regional investigations to address complex issues in biological QC assays used for release testing of our vaccines.
• Independently performing method transfers and conducting gap assessments to ensure compliance, quality and efficiency in QC processes as part of network restructuring.
• Supporting strategic development and managing the execution of local and regional remediation, robustness, and compliance programs.
• Supporting or leading global and regional harmonization initiatives, including the development of guidelines and training for QC practices.
• Presenting detailed technical reports to sponsors and relevant stakeholders, summarizing findings and recommendations.
• Acting as a representative for shop floor concerns related to QC assay remediation and improvement efforts in project teams and sponsor meetings.
• Provide routine updates on business challenges, significant achievements, and technical information to stakeholders.
• Train and mentor junior ATS-Bio colleagues to enhance their skills and knowledge in biological QC processes.
• Conduct complex data and trend analyses to identify root causes and design hypothesis testing for QC laboratories.

Your profile

• A completed Bachelor of Applied Science (BSc) or Master of Science (MSc) degree in Biochemistry, Biology, Molecular Biology, or a related field.
• Extensive experience in the pharmaceutical or biotechnology industry, specifically in the analytics of large molecules (vaccines).
• Proven expertise in biological assay performance, including remediation, troubleshooting, development, validation, and transfer of biological QC tests gaining strong experience in multiple laboratory techniques such as ELISA, PCR, cell culture, virus titration, and other relevant microbiological techniques.
• Strong understanding of Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements.
• Strong data analysis skills, including experience with statistical software (e.g., Minitab, Aera), and a demonstrated ability to identify root causes and implement solutions.
• Excellent communication skills, both verbal and written, with the ability to present technical information clearly to stakeholders and manage multiple projects effectively.
• Good command of the Dutch and English language.
• Living at a reasonable distance of Boxmeer.

What we offer

The opportunity to join our innovative team in Boxmeer and play a crucial role in ensuring the quality, reliability and supply of our Animal Health products across Europe. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• Competitive salary and a 3% year-end allowance.
• 35,5 days of leave.
• Attractive collective health care insurance package with considerable reduction rates.
• Solid Pension Plan.
• Annual bonus based on own and company performance.
• Travel allowance for commuting.
• Numerous training, coaching and e-learning modules for long term job opportunities and development.

Animal Health

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Do you have questions about this job vacancy?
Send your question, including the job number and job title, to the following email address: RecruitmentNL@MSD.com

Required Skills:

Assay, Assay Development, Biochemical Assays, Biological Sciences, Biosecurity, Cell-Based Assays, Cell Cultures, Cell Physiology, Communication, Documentations, Enzyme Linked Immunosorbent Assay (ELISA), Enzymology, Hemagglutination Assays, Immunochemistry, Mammalian Cell Culture, Management Process, Microbiological Analysis, Microbiology, Molecular Biology, Molecular Microbiology, Pharmaceutical Management, Physiology, Polymerase Chain Reaction (PCR), Project Management