Senior Bioassay Method Transfer Specialist

MSD España

Salamanca

Presencial

EUR 90.000 - 130.000

Jornada completa

hace 17 horas
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Descripción de la vacante

MSD España seeks a Senior Method Transfer Specialist (Bioassays) in Salamanca to coordinate and drive robust large molecule analytical method transfers across the EU and APAC network. You will act as a subject-matter expert to support early assay development, transfer readiness, and right-first-time implementation.

You will collaborate with R&D, QC, QA and other stakeholders, leading cross-functional activities and ensuring regulatory and GMP compliance throughout development, validation and

Formación

  • Bachelor’s or Master’s degree in Biological Sciences, Pharmaceutical Sciences, Analytical Sciences, or a related discipline.
  • Multi-year experience in pharma/biotech analytics for large molecules (bioassays) with method transfer.
  • Strong expertise in biological QC assays and troubleshooting in GxP.
  • Solid programming in statistical analysis and data interpretation.

Responsabilidades

  • Coordinate and execute large molecule analytical method transfers across EU & APAC.
  • Lead transfer plans with timelines, milestones, documentation, and readiness criteria.
  • Review transfer documentation and align with R&D/QC on acceptance criteria and standards.
  • Provide expert troubleshooting and data-driven guidance across method development, validation, transfer and implementation.
  • Lead complex, multi-site transfer workstreams and risk assessments; drive investigations and remediation.
  • Collaborate with R&D, QC, QA, RA, and other network partners to ensure smooth transfer execution.

Conocimientos

Bioanalytical methods
GxP compliance
Immunoassays
Cell-based assays
Statistical analysis
Project management
Cross-functional collaboration
Regulatory knowledge

Educación

Bachelor’s or Master’s in Biological Sciences

Herramientas

Minitab

Descripción del empleo

MSD España seeks a Senior Method Transfer Specialist (Bioassays) in Salamanca to coordinate and drive robust large molecule analytical method transfers across the EU and APAC network. You will act as a subject-matter expert to support early assay development, transfer readiness, and right-first-time implementation.

You will collaborate with R&D, QC, QA and other stakeholders, leading cross-functional activities and ensuring regulatory and GMP compliance throughout development, validation and

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