Senior Specialist, Method Transfers

Merck · Salamanca (el Montalvo Parc.39), Spain

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Role summary

Merck seeks a Senior Specialist for Method Transfers in Salamanca to lead analytical method transfers for large molecules across EU/APAC sites. The role involves coordinating transfer projects, providing technical expertise in bioassays, and collaborating across R&D, QC, and regulatory functions within the animal health division.

What they're looking for

Bachelor's or Master's degree in Biological Sciences, Pharmaceutical Sciences, or Analytical Sciences
Multi-year experience in large molecule analytics (bioassays, vaccines) in pharmaceutical or biotechnology
Extensive hands-on experience in analytical method development, validation, and transfer in GxP environments
Strong expertise in biological QC assays including immunoassays, cell-based assays, and PCR
Proficiency in statistical software such as Minitab or equivalent analytical tools
Strong project management skills and ability to lead complex technical analytical work independently
Knowledge of GMP/GLP, change control, deviations/CAPA, and large-molecule regulatory requirements

What you'll be doing

Execute large molecule analytical method transfers across EU and APAC network sites as technical lead
Prepare and lead transfer plans including timelines, milestones, documentation, and cost planning
Conduct risk and gap assessments; review transfer documentation and align acceptance criteria with stakeholders
Provide troubleshooting support and technical guidance throughout method development, validation, and implementation
Lead multi-site transfer workstreams, coordinate cross-functional activities, and perform statistical analyses

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