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Sr QC Scientist (ASAT) Leiden • Panda International
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Gevraagd
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37 - 40 uur
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Medior/Senior
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Engels (taal)
Aanbod
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Tijdelijk contract
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An international biopharmaceutical company is seeking an Interim Senior QC Scientist (ASAT) to support the technology transfer of cell therapy products to decentralized manufacturing units (DMUs) across Europe. This hands-on role will play a key part in method transfer, training, and process improvements within a GMP-regulated QC environment.
Key Details:
Start Date: ASAP
Contract Duration: 6 months
Location: Leiden, Netherlands (with 20–30% EU travel)
Languages: English required
Commitment: Full-time preferred
Interview Process: 1-2 stages
Technology Transfer – Lead and execute method transfers for Galapagos cell therapy products to multiple DMUs across Europe.
Method Training – Train site operators on key QC methods, including Flow Cytometry, Endotoxin, Mycoplasma, VCN, Potency, and Cell Counting.
Documentation & Review – Review and approve procedures, protocols, and reports related to method implementation.
Compliance Support – Actively manage and support deviations, CAPAs, and change controls related to method transfers.
Process Optimization – Implement improvements in analytical methods and tech transfer workflows.
On-Site Support – Provide hands-on support during TT runs at DMUs and ensure readiness.
External Coordination – Liaise with Contract Testing Labs (CTLs) for method validation and sample testing.
BSc/MSc in Life Sciences, Biotechnology, or a related discipline.
5–10 years’ experience in the pharma/biotech industry, particularly in QC or analytical development.
Solid knowledge of method transfer, validation, and method lifecycle management.
Hands-on experience with analytical techniques such as Flow Cytometry, PCR, and Cell-Based Assays.
Strong working knowledge of GMP regulations and compliance requirements.
Excellent communication and stakeholder engagement skills.
Comfortable with changing priorities and capable of working in fast-paced environments.
Fluent in English (written and spoken).
Willingness and ability to travel within Europe (20–30%).
Pan-European Scope – Be at the forefront of analytical tech transfer across international decentralized manufacturing sites.
Cutting-Edge Cell Therapy – Work directly with advanced methods and innovative product platforms.
Collaborative Environment – Join a cross-functional team within a fast-growing biopharma environment.
Hands-On Impact – Play a key role in empowering DMUs and strengthening analytical capability
1st Interview – With ASAT leadership team
2nd Interview – With project stakeholders if required
Start Date: ASAP
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