Method Transfer Specialist (Bioassays)
Hybrid · Boxmeer, North Brabant, The Netherlands
Job Summary
Coordinate and execute analytical method transfers for large-molecule bioassays within the ATS-Bio network, leading single-site and moderately complex transfer workstreams, performing hands-on laboratory activities to support method improvements and fit-for-transfer adjustments, and generating robust transfer documentation (risk/gap assessments, protocols, reports) to enable right-first-time transfer. Act as analytical lead for investigations, collaborate with R&D, QC, QA, RA, and cross-functional teams, ensure adherence to GxP and site procedures, and support lifecycle activities such as robustness trending and remediation. Requires hands-on experience with biological QC assays (ELISA, cell-based assays, virus titration, PCR), ability to design experiments, interpret data, and communicate progress to senior team members; fluency in Dutch and English; proximity to Boxmeer for commuting.
Required Qualifications
- Bachelor of Applied Science (BSc) or Master of Science (MSc) in Biochemistry, Biology, Molecular Biology, or related field
- Proven experience in biological/large-molecule analytics in a GxP lab (QC or R&D) including method development, execution, improvement, validation, transfer activities, data review and documentation
- Practical hands-on experience in biological QC assays (ELISA, cell-based assays, virus titration, PCR) including troubleshooting and robustness evaluation
- Familiarity with project management, robustness/lifecycle concepts and biomaterials handling in QC assays
- Working knowledge of data analysis and statistical software (e.g., Minitab)
- Proficiency with standard digital tools
- Strong teamwork, communication, and organizational skills; ability to follow procedures and meet timelines in a cross-functional environment
- Good command of Dutch and English
Additional Requirements
- Based within a reasonable commuting distance of Boxmeer
- No explicit visa sponsorship restrictions beyond standard MSD policy
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