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Sr QC Scientist (ASAT)

Sr QC Scientist (ASAT)

LocationLeiden, Netherlands
Business SectorBiotechnology
Contact nameCaitlin Girdwood
Contact email
Job ref24926
Published2 days ago

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

Responsibilities

  • 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.

Requirements

  • 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%).

Why This Role?

  • 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

Interview Process

  • 1st Interview – With ASAT leadership team

  • 2nd Interview – With project stakeholders if required

  • Start Date: ASAP