| Location | Leiden, Netherlands |
|---|---|
| Business Sector | Biotechnology |
| Contact name | Caitlin Girdwood |
| Contact email | |
| Job ref | 24818 |
| Published | 1 day ago |
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
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.
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.
High-Impact Science – Play a central role in the release and standardization of CAR-T therapies that change lives.
Long-Term Opportunity – 12-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.
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
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.
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.
High-Impact Science – Play a central role in the release and standardization of CAR-T therapies that change lives.
Long-Term Opportunity – 12-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.
1st Interview – With Hiring Manager & QC Sciences team
2nd Interview – If needed
Quick Feedback & Decision Process