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Open nowPosted 565 days ago

Scientist, Biotech Manufacturing (Immunology, BioTech)

matresearch9 open roles

Where
Leiden, Zuid-Holland, Netherlands
Work mode
On site
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Your applicationOpen nowScientist, Biotech Manufacturing (Immunology, BioTech)matresearch · Leiden, Zuid-Holland, Netherlands

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This job: posted 565 days ago

The posting

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 Manufacturing Scientist to play a crucial role in developing, optimising, and overseeing our biotech manufacturing processes. You will work at the intersection of scientific research, manufacturing operations, and quality control, ensuring consistency and scalability of high-quality product manufacturing and delivery within regulatory compliance.

This role is ideal for individuals with a strong scientific background in immunology and hands-on experience in biotech production environments.

Your key responsibilities will include:

  • Manufacturing Process Development & Optimization
  • Manufacturing Operations & Quality Control
  • Data Analysis & Process Validation
  • Manufacturing Technology

To fulfill these responsibilities, you will:

  • Develop, refine, and scale manufacturing workflows for MAT kit production.
  • Ensure consistency, reproducibility, and scalability of manufacturing processes.
  • Act as the scientific expert on the production floor, supporting manufacturing teams during production.
  • Work with cross-functional teams to troubleshoot and optimise production efficiency.
  • Oversee batch manufacturing processes, reagent preparation, and formulation of diagnostic kits.
  • Implement and enforce GMP, ISO:9001, and regulatory compliance standards.
  • Monitor key quality parameters and conduct in-process checks to maintain high product standards.
  • Collect and analyse process data to identify improvements and optimise manufacturing performance.
  • Conduct process validation studies to ensure reliability and compliance with regulatory requirements.
  • Collaborate with QA/QC teams to investigate process deviations and implement corrective actions.
  • Support technology transfer from R&D to manufacturing, ensuring seamless transition and implementation.
  • Drive process automation and integration of advanced bioprocessing techniques.
  • Train and mentor technicians and operators in best manufacturing practices.
  • Act as the technical expert for manufacturing-related challenges and improvements.
  • Work closely with R&D, Quality, and Regulatory teams to maintain alignment on product development and compliance.
  • Living in the Netherlands near Leiden or able to relocate in the short term.
  • PhD in STEM fields like immunology, biology, chemistry, or engineering, with a solid academic track record.
  • At least 5 years of hands-on experience in chemical/biological labs, backed by a strong grasp of good laboratory practices.
  • Extensive, hands-on experience in PBMC isolations, cellular assays, and analytical-based assays (ELISA, Flow Cytometry) according to regulatory standards such as ICH.
  • Experience with pyrogen testing, human immune response assays, and cytokine detection is a strong plus.
  • Strong understanding of GMP, ISO:9001, and regulatory compliance in biotech production.
  • Experience with scale-up, process validation, and technology transfer.
  • Analytical mindset with proficiency in data analysis and process optimisation.
  • Excellent problem-solving and cross-functional collaboration skills.
  • Comfortable with inventory and logistics software, capable of managing resources efficiently.
  • Innovative with an entrepreneurial attitude, looking beyond what is possible and known.
  • Self-starter with teamwork skills, adept at juggling priorities to nail deadlines.
  • Willing to hit the road for occasional business trips.
  • Fluent in English; proficiency in Dutch, German, or French is a major plus.

Your compensation will be:

  • Competitive base salary (Full-time 40 h/week)
  • Twenty-five vacation days per year and your National Holidays off.
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