Quality Control Scientist (Biotech & In Vitro Immunology)
MAT Research is a pioneering company in the field of pyrogen testing, committed to ushering in a new era of ethical and accurate diagnostics. Since 2016, we have been leading the development of the Monocyte Activation Test (MAT), an animal-free alternative to traditional Rabbit Pyrogen Tests. Our ready-to-use MAT kits offer a robust and highly reliable method for detecting a broad range of pyrogens in parenteral drugs. ISO:9001:2015 certified, we uphold the highest standards of quality in all our products and services. By focusing on in vitro human based testing, we aim to drastically increase patient safety while saving hundreds of thousands of animal lives each year. We are steadfast supporters of the European Pharmacopoeia's vision to replace animal-based tests with MAT by 2026. For more details, go to our job page.
As we continue to scale, we are looking for a dedicated QC Scientist to ensure the accuracy, reliability, and compliance of quality control processes through optimisation, validation, and data-driven decision-making.
Your key responsibilities will include:
QC Process Optimisation and Control
Quality Assurance and Compliance
Data Integrity and Analysis
Team Leadership and Validation
Product Testing and Validation
Collaboration and Reporting
To fulfill these responsibilities, you will:
Implement and monitor quality control standards to ensure production excellence.
Optimise manufacturing processes to increase efficiency and quality.
Uphold stringent quality assurance standards to meet internal and regulatory requirements.
Conduct regular audits and reviews to ensure compliance with industry standards (e.g., ISO9001, GMP).
Maintain meticulous records of all quality tests and results.
Analyse data from production and QC tests to identify trends and areas for improvement.
Lead and train team members to ensure high performance and adherence to quality standards.
Develop training materials and protocols for quality control procedures.
Oversee and execute product testing methods to validate the quality of products.
Implement new testing techniques and technologies to enhance product reliability.
Collaborate with R&D and production teams to integrate quality control measures throughout the manufacturing process.
Prepare detailed reports on quality control outcomes, challenges, and process improvements.
Requirements
Living in the Netherlands near Leiden or able to relocate in the short term.
PhD or MSc in Immunology, Immuno-oncology, Immunotherapy, Cell Biology, or related discipline. (PhD strongly preferred)
At least 5+ years of industry experience (Biotech, Pharma, or CRO) in immunology-focused R&D - ideally in a scale-up or high-growth environment.
Extensive, hands-on experience in PBMC isolations, cellular assays, and analytical-based assays (ELISA, Flow Cytometry) according to regulatory standards such as ICH.
In vitro assay development and validation (ELISA, cell-based assays, endotoxin testing, etc.).
Quality Control (QC) Testing experience in a GMP-regulated environment.
Hands-on experience with Monocyte Activation Test (MAT) and alternative pyrogen testing methods.
Proficiency in using analytical instruments (HPLC, PCR, spectrophotometry, flow cytometry).
Knowledge of sterility testing, bioburden analysis, and endotoxin detection (LAL, rFC assays).
Experience with method validation, qualification, and troubleshooting of bioassays.
Strong problem-solving and troubleshooting abilities.
Attention to detail and excellent documentation skills (writing protocols, reports, SOPs).
Ability to handle multiple projects and meet tight deadlines in a fast-paced environment.
Experience with risk assessments, CAPAs, deviation investigations in QC.
Understanding of pharmacopoeial requirements (USP, EP) for pyrogen testing.
Your compensation will be:
Competitive base salary (Full-time 40 h/week)
Twenty-five vacation days per year and your National Holidays off.