Senior Bioassay Method Transfer Specialist

MSD Malaysia; Salamanca; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

MSD in Salamanca is seeking a Senior Specialist, Method Transfers to coordinate and execute analytical transfers for large molecules across EU and APAC. You will serve as a subject‑matter expert, driving method development, validation, and transfer readiness while collaborating with R&D, QC, QA, RA, and Data Science teams.

The role requires strong analytical depth, problem‑solving, and effective cross‑functional communication, with a focus on ensuring right‑first‑time transfer implementation at

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 of large molecules (bioassays) in GxP environments.
• Hands‑on experience in analytical method development, validation, testing and transfer for biological/large‑molecule products.
• Strong technical expertise in biological QC assays (immunoassays, cell‑based assays, virus titration, PCR).
• Proficiency with statistical software such as Minitab or equivalent.

Responsabilidades

• Provide expert support and execute large molecule analytical method transfers across EU & APAC networks, guiding early assay development.
• Prepare and lead transfer plans with timelines, milestones, documentation, transfer readiness criteria, resource and cost planning.
• Lead risk and gap assessments; prepare key transfer documentation (protocols, reports) with alignment across R&D/QC stakeholders.
• Serve as SME for large molecule bioanalytical methods; troubleshoot, provide data‑driven guidance across development to implementation.
• Lead multi‑site transfer workstreams; coordinate cross‑functional activities and drive investigations and remediation actions.

Conocimientos

Analytical problem solving

cGMP compliance

Data analysis

Inventory management

Lean Six Sigma

Manufacturing technologies

Process improvements

Process optimization

Production planning

Production scheduling

Vaccine manufacturing

Educación

Bachelor’s/Master’s in Biological/Pharmaceutical/Analytical Sciences or related

Herramientas

Minitab

Descripción del empleo

MSD in Salamanca is seeking a Senior Specialist, Method Transfers to coordinate and execute analytical transfers for large molecules across EU and APAC. You will serve as a subject‑matter expert, driving method development, validation, and transfer readiness while collaborating with R&D, QC, QA, RA, and Data Science teams.

The role requires strong analytical depth, problem‑solving, and effective cross‑functional communication, with a focus on ensuring right‑first‑time transfer implementation at