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QC Flow Cytometry Specialist Leiden Panda International

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Gevraagd

  • 37 - 40 uur
  • Engels (taal)

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  • Tijdelijk contract
 

Vacature in het kort

Leiden
An international biopharmaceutical company is looking for a Flow Cytometry Core Specialist to join the Global QC Sciences team. You will work on standardizing flow cytometry methods and managing CAPA in a GMP setting. This role is key in developing CAR-T therapies. Consultants are seen as key contributors, offering a truly empowered consulting environment. Read on to discover how this opportunity can transform your career.
 

Over het bedrijf

Panda International
Bedrijfsprofiel
 

Volledige vacaturetekst

An international biopharmaceutical company is seeking a highly motivated Flow Cytometry Core Specialist to join the Global QC Sciences team. This role will focus on flow cytometry method standardization, trending analysis, and CAPA management within a GMP Quality Control setting, supporting the development and release of CAR-T therapies.

Key Details:

  • Start Date: ASAP

  • Contract Duration: Minimum 12 months

  • Location: Leiden, Netherlands (Hybrid, weekly on-site presence required)

  • Languages: English required

  • Availability: Ideally full-time

Responsibilities
  • Flow Cytometry Support – Drive standardization and harmonization of flow cytometry instruments across QC sites.

  • QC Trending & Analysis – Perform trending analyses of assay parameters; manage OOS/OOT results and ensure assay performance meets quality standards.

  • CAPA & Root Cause Management – Lead root cause investigations and CAPA activities for flow cytometry deviations in a GMP-QC environment.

  • Method Qualification & Validation – Support qualification, validation, and bridging of new flow cytometry methods, aligning with ICHQ2-R2.

  • Best Practice Implementation – Enable decentralized QC model enhancements through best practice sharing and method lifecycle expertise.

  • Cross-Functional Collaboration – Work closely with Analytical Development and QC Sciences teams to support CAR-T drug product strategy and release.

Requirements
  • Strong flow cytometry expertise (instrument standardization and data analysis).

  • Experience in oncology and cell therapy experience preferred.

  • Demonstrated experience in QC trending, method lifecycle management, and GMP settings.

  • Skilled in managing OOS/OOT results, CAPAs, and root cause analysis.

  • Deep knowledge of ICHQ2-R2 for method qualification and validation.

  • Proactive, quality-focused, and comfortable working under tight deadlines.

  • Excellent communication and collaboration skills across scientific and QC teams.

Why This Role?
  • High-Impact Science – Play a central role in the release and standardization of CAR-T therapies that change lives.

  • Long-Term Opportunity12-month contract with potential for further project involvement.

  • Global Collaboration – Join a cross-functional QC sciences team with strategic influence on global QC and method transfer.

  • Empowered Consulting Environment – Consultants are treated as key contributors, not external resources.

Interview Process
  • 1st Interview – With Hiring Manager & QC Sciences team

  • 2nd Interview – If needed

  • Quick Feedback & Decision Process

An international biopharmaceutical company is seeking a highly motivated Flow Cytometry Core Specialist to join the Global QC Sciences team. This role will focus on flow cytometry method standardization, trending analysis, and CAPA management within a GMP Quality Control setting, supporting the development and release of CAR-T therapies.

Key Details:

  • Start Date: ASAP

  • Contract Duration: Minimum 12 months

  • Location: Leiden, Netherlands (Hybrid, weekly on-site presence required)

  • Languages: English required

  • Availability: Ideally full-time

Responsibilities
  • Flow Cytometry Support – Drive standardization and harmonization of flow cytometry instruments across QC sites.

  • QC Trending & Analysis – Perform trending analyses of assay parameters; manage OOS/OOT results and ensure assay performance meets quality standards.

  • CAPA & Root Cause Management – Lead root cause investigations and CAPA activities for flow cytometry deviations in a GMP-QC environment.

  • Method Qualification & Validation – Support qualification, validation, and bridging of new flow cytometry methods, aligning with ICHQ2-R2.

  • Best Practice Implementation – Enable decentralized QC model enhancements through best practice sharing and method lifecycle expertise.

  • Cross-Functional Collaboration – Work closely with Analytical Development and QC Sciences teams to support CAR-T drug product strategy and release.

Requirements
  • Strong flow cytometry expertise (instrument standardization and data analysis).

  • Experience in oncology and cell therapy experience preferred.

  • Demonstrated experience in QC trending, method lifecycle management, and GMP settings.

  • Skilled in managing OOS/OOT results, CAPAs, and root cause analysis.

  • Deep knowledge of ICHQ2-R2 for method qualification and validation.

  • Proactive, quality-focused, and comfortable working under tight deadlines.

  • Excellent communication and collaboration skills across scientific and QC teams.

Why This Role?
  • High-Impact Science – Play a central role in the release and standardization of CAR-T therapies that change lives.

  • Long-Term Opportunity12-month contract with potential for further project involvement.

  • Global Collaboration – Join a cross-functional QC sciences team with strategic influence on global QC and method transfer.

  • Empowered Consulting Environment – Consultants are treated as key contributors, not external resources.

Interview Process
  • 1st Interview – With Hiring Manager & QC Sciences team

  • 2nd Interview – If needed

  • Quick Feedback & Decision Process

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