Senior Specialist, Method Transfers

Merck; Salamanca; Presencial; EUR 90.000 - 110.000; Jornada completa

Descripción de la vacante

Merck is seeking a Senior Method Transfer Specialist (Bioassays) based in Salamanca to coordinate and execute analytical transfers for large-molecule products. You will act as a subject-matter expert to drive early-phase development, transfer readiness and right-first-time implementations across R&D and QC laboratories.

You will lead cross-functional teams, review documentation, and ensure alignment with regulatory expectations (GxP).

Formación

• Bachelor's or Master's degree in Biological Sciences, Pharmaceutical Sciences, Analytical Sciences, or related.
• Multi-year experience in pharma/biotech analytics of large molecules (bioassays).
• Experience in analytical method development, validation, transfer in GxP environments.
• Strong knowledge of GMP/GLP expectations and transfer documentation.

Responsabilidades

• Coordinate and execute large molecule analytical method transfers across EU/APAC.
• Lead transfer plans with timelines, milestones, and documentation.
• Review protocols and reports; ensure readiness criteria and acceptance criteria.
• Provide troubleshooting and data-driven analytical guidance across development, transfer and implementation.
• Coordinate cross-site transfer workstreams; drive investigations and remediation actions.
• Build relationships with R&D, QC, QA, RA and Data Science teams.

Conocimientos

Analytical depth

Project management

Negotiation & influence

Communication skills

Cross-functional collaboration

GMP/GLP knowledge

R&D-QC interface

Bilingual: Spanish & English

Educación

Bachelor's or Master's in Biological/Pharmaceutical/Analytical Sciences

Herramientas

Minitab

Descripción del empleo

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, Global 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