Job Description

An amazing opportunity has arisen for a Senior Specialist, Method Transfers in the EU/APAC network based in Salamanca .

Our Global Science & Technology (S&T;) division applies science, technology and innovation to support new product commercialization and ensure supply continuity for animal health manufacturing. S&T; continuously improves processes and analytics to meet customer needs through manufacturing excellence. Within S&T;, Integral Analytical Technology Solutions (ATS) oversees analytical activities across the Animal Health network. To strengthen and centralize Large Molecule analytical method transfers across the EU/APAC network, we are building a new Bio Method Transfer team of up to five employees. To strengthen this team and to provide expert support, we are looking for a Senior Method Transfer Specialist (Bioassays).

This position will be responsible for coordinating and executing analytical method transfers for large molecules across R&D; and QC laboratories, while acting as a key subject-matter expert to drive robust early-phase method development and transfer readiness.

The successful candidate will ensure right-first-time method implementation at receiving QC sites and will work collaboratively with stakeholders across R&D;, QC, QA, (G)RA, and other technical functions. This role requires strong technical analytical depth, independent complex problem-solving skills, and the ability to contribute within a highly cross-functional environment, reporting into the ATS-Bio Method Transfer Team lead.

What you will do:

Bring energy, knowledge, innovation and project leadership to carry out the following:

- Provide expert support and execute large molecule analytical method transfers across the EU & APAC network, acting as a sparring partner for R&D; during early assay development to ensure method robustness,



platform suitability, biomaterials, and QC feasibility.
- Prepare and lead transfer plans for assigned methods, including timelines, milestones, documentation, transfer readiness criteria, resource planning, and cost planning at project level.
- Lead risk and gap assessments, and prepare and review key transfer documentation such as protocols and reports, while aligning with R&D; and QC stakeholders on readiness, acceptance criteria, specification settings, documentation standards, and execution.
- Serve as a subject matter expert for large molecule bioanalytical methods, providing troubleshooting, data-driven analytical advice, and technical guidance throughout method development, improvement, validation, transfer, and implementation.
- Lead complex or multi-site transfer workstreams, coordinate cross-functional activities, drive technical investigations and remediation actions, and perform advanced data analyses and statistical evaluations to support successful implementation at QC sites. Lab-related activities to support method improvements, method optimization, robustness checks, and final fit-for-transfer adjustments can be in scope.
- Build strong relationships across R&D;, QC, QA, RA, BTS, Data Science, and other network partners, provide clear communication and escalation when needed, and contribute to strategy, governance decisions, and analytical lifecycle maturity initiatives.

What skills you will need:





In order to excel in this role, you will more than likely have:

- Bachelor's or Master's degree in Biological Sciences, Pharmaceutical Sciences, Analytical Sciences, or a related discipline.
- Multi-year experience in the pharmaceutical or biotechnology industry, specifically in the analytics of large molecules (bioassays, vaccines). Extensive hands-on experience in analytical method development, validation, testing, and method transfer for biological or large-molecule products in GxP environments.
- Strong technical expertise in biological QC assays, including immunoassays, cell-based assays, virus titration, and PCR, with proven capability in troubleshooting, remediation, and robustness evaluation.
- Strong analytical and problem-solving skills, with proficiency in statistical software such as Minitab or equivalent tools.
- Strong project management skills and the ability to independently lead complex technical analytical work packages.
- Proven negotiation and influencing skills to harmonize competing priorities, and ability to coordinate cross-functional activities and deliver high-quality technical output.
- Effective communication and interpersonal skills to work smoothly across R&D;, QC, QA, RA, BTS, Data Science, and other stakeholders.
- Solid working knowledge of GMP/GLP expectations, change control, deviations/CAPA, and transfer documentation processes.
- Experience at the interface between R&D; and QC, with familiarity in analytical lifecycle management, method robustness initiatives, cross-site harmonization programs, and large-molecule regulatory and compliance requirements such as VICH and Ph.Eur.
- Good command of the Spanish and English language.

Based within a reasonable commuting distan

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📌 Senior Specialist, Method Transfers (Salamanca)
🏢 Merck
📍 Salamanca