Large Molecule Biocritical Reagents Specialist

Job Description

We are looking for a Specialist to join the ATS-Bio Technical Life Cycle Management Biomaterials team. The ATS-Bio Technical Life Cycle Management Biomaterials team supports the establishment and execution of harmonized lifecycle management for critical biomaterials used in LM QC assays.

Biomaterials are biological reagents playing a critical role in bioassays, which are produced in-house or purchased commercially,  Due to their critical role in bioassays, biomaterials are considered critical assets and an Integrated Risk Management (IRM) program was initiated.

Main responsibilities for this Specialist role, will be to manage the Integrated Risk Management (IRM) program together with relevant QC sites, establishing a detailed risk overview per biomaterial, followed by additional in depth data evaluation of the QC test in which the biomaterial is used, and where needed, defining a roadmap to mitigate these risks and support in execution thereof.

In this Specialist role, you contribute to reliable assay performance, reduced biomaterial-related supply risk, and consistent, on-time product supply.

Key responsibilities

• Support the IRM program by collecting and structuring technical information for critical biomaterials, including current use, availability, criticality, qualification status, documentation gaps, replacement readiness, and supply continuity risks.
• Contribute to detailed risk identification and mitigation by compiling critical biomaterial and assay data, followed by defining, planning and monitoring of  a mitigation roadmap with relevant stakeholders.
• IRM risk mitigation activities including for example, supporting in documentation gathering, protocol writing, data evaluation and report writing.
• Support characterization (e.g., biological, chromatographical) and qualification activities for new, replacement, or transferred biomaterial batches, including data generation & evaluation, and documentation of results.
• Support biomaterial transfers and routine replacements for inline QC bioassays.
• Contribute to continuous improvement by identifying opportunities to standardize procedures, improve documentation quality, reduce variability, and strengthen biomaterial robustness and supply continuity.
• Contribute to biomaterial lifecycle management by establishing realistic replacement timelines and minimum stock limits.
• Assist in biomaterial-related investigations and troubleshooting by compiling and analyzing historical and current assay data, identifying potential technical causes, and supporting implementation of corrective and preventive actions.

Qualifications

• Holds a Bachelors, Masters or PhD degree in Biology, Biochemistry, Biotechnology, Chemistry, Pharmacy, or a related scientific discipline, or equivalent relevant laboratory experience.
• 2-5 years, dependent on education level, of practical experience in a pharmaceutical, biological, vaccine, QC, R&D, BTS, or analytical laboratory environment, with biomaterials or biological QC assays.
• Hands-on knowledge of three or more relevant techniques, such as ELISA, immunoassays, virus titration, cell culture, antibody or antigen handling, protein purification, conjugation, serum processing, or stability and qualification testing.
• Experience in managing projects or programs and communicating effectively with stakeholders is considered a strong pre.
• Good communication and collaboration skills, with the ability to work in multidisciplinary and international teams and to clearly document and present technical information.
• Proficiency in English and preferably Dutch; experience with LIMS, document management systems, Excel, or data analysis tools is considered an advantage.

Additional Information

Working at PSS means working in a team where people support each other, take responsibility for their work and stay closely connected to the client environment they work in. You will be part of an international setting, with colleagues who value clear communication, teamwork and a good working atmosphere.

We believe it is important that people can keep developing in their role. That is why we offer specialist training and opportunities to build your knowledge and skills further. We also make time to stay connected as a team, for example through monthly team lunches, team activities and moments where colleagues are recognized for their contribution. We offer:

• A responsible position within the team;
• Room to share your ideas and input;
• Specialist training and opportunities for personal and professional development;
• 31 vacation days per year based on a full-time employment contract, with the option to purchase 5 additional days;
• The option to use gross/net benefit schemes for sports and the purchase of a bicycle;
• Access to an online preventive mental health platform;
• A flexible start time between 07:00 and 09:00, depending on team planning and operational needs;
• A suitable salary and additional benefits.

Working at PSS gives you the personal approach of a medium-sized organization, with the wider network and structure of Eurofins as a parent company. In your work, you regularly interact with other companies and scientists within the Eurofins group, which brings variety to the role.

This also means there may be opportunities to grow, depending on your role, experience and development.

Would you like to know more?
For questions about the position, you can contact the hiring team via the ‘I’m interested’ button below.

Acquisition for this vacancy is not appreciated.