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Method Transfer Specialist (Bioassays)

msd · ESP - Salamanca - Salamanca (El Montalvo Parc.39)

New
Mid 🇬🇧 English
Minitab GxP GMP GLP Analytical method transfer Immunoassays PCR Data analysis

Job description

About the role

MSD's Global Science & Technology division, which supports animal health manufacturing, is building a new Bio Method Transfer team of up to five people. It is looking for a Method Transfer Specialist (Bioassays) in Salamanca to coordinate and execute analytical method transfers for large molecules between R&D and QC Salamanca laboratories, and to act as a subject-matter expert for method development and transfer readiness. The role reports to the ATS-Bio Method Transfer Team lead.

Key responsibilities

  • Support the execution of analytical method transfers for large molecule bioassays with R&D and QC Salamanca teams.
  • Help prepare transfer plans, including timelines, documentation, readiness criteria and activity coordination.
  • Take part in risk and gap assessments and support the preparation and review of transfer protocols and reports.
  • Work with stakeholders so that methods are transferred robustly, fit-for-purpose and compliant.
  • Support troubleshooting and technical investigations during method development, validation, transfer and implementation.
  • Assist with data review and analysis to support transfer decisions and method readiness.
  • Contribute to continuous improvement of analytical method transfer processes and laboratory readiness.

Required profile

  • Bachelor's or Master's degree in Biological Sciences, Pharmaceutical Sciences, Analytical Sciences or a related field.
  • Around 3 years of experience in the pharmaceutical or biotechnology industry, ideally in analytical bioassay development or method transfer for large molecules.
  • Practical experience in GxP environments, with exposure to method development, validation, testing or transfer.
  • Familiarity with biological QC assays such as immunoassays, cell-based assays, virus titration or PCR.
  • Good command of Spanish and English; based near Salamanca or willing to relocate.

Required skills

  • GxP, GMP/GLP basics, change control, CAPA and transfer documentation.
  • Analytical and problem-solving skills, with statistical or data analysis tools such as Minitab.
  • Ability to work in a cross-functional environment and communicate with technical stakeholders.

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Source : ats:workday

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Published 10 hours ago

Expires 1 month from now

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msd

ESP - Salamanca - Salamanca (El Montalvo Parc.39)