Senior Specialist – Method Transfers (Bioassays)

About the role

An exciting opportunity exists for a Senior Specialist in Method Transfers within Merck's Global Science & Technology division, based in Salamanca. The role focuses on coordinating and executing analytical method transfers for large‑molecule bioassays across the EU/APAC network, ensuring robust early‑phase development and right‑first‑time implementation at QC sites.

Key responsibilities

• Provide expert support and execute large‑molecule analytical method transfers across the EU & APAC network, partnering with R&D during early assay development.
• Prepare and lead transfer plans, including timelines, milestones, documentation, resource and cost planning.
• Lead risk and gap assessments, review protocols and reports, and align acceptance criteria with R&D and QC.
• Serve as subject‑matter expert for bioanalytical methods, offering troubleshooting, data‑driven advice and technical guidance throughout development, validation and implementation.
• Coordinate multi‑site transfer workstreams, drive investigations, perform advanced data and statistical analyses to ensure successful QC site implementation.

Required profile

• Bachelor’s or Master’s degree in Biological, Pharmaceutical or Analytical Sciences.
• Several years of experience in pharma/biotech analytics of large molecules (bioassays, vaccines) in GxP environments.
• Strong technical expertise in immunoassays, cell‑based assays, virus titration and PCR, with proven troubleshooting ability.
• Proficiency with statistical software such as Minitab and solid project‑management capabilities.
• Excellent communication skills and ability to work cross‑functionally with R&D, QC, QA, RA and data‑science teams.

Required skills

• Minitab (statistical analysis)
• PCR
• Immunoassays
• Cell‑based assays
• Virus titration
• Large‑molecule bioanalytical methods
• GMP/GLP compliance