Senior Specialist, Method Transfers

MSD España; Salamanca; Presencial; EUR 90.000 - 130.000; Jornada completa

Descripción de la vacante

MSD España seeks a Senior Method Transfer Specialist (Bioassays) in Salamanca to coordinate and drive robust large molecule analytical method transfers across the EU and APAC network. You will act as a subject-matter expert to support early assay development, transfer readiness, and right-first-time implementation.

You will collaborate with R&D, QC, QA and other stakeholders, leading cross-functional activities and ensuring regulatory and GMP compliance throughout development, validation and

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 for large molecules (bioassays) with method transfer.
• Strong expertise in biological QC assays and troubleshooting in GxP.
• Solid programming in statistical analysis and data interpretation.

Responsabilidades

• Coordinate and execute large molecule analytical method transfers across EU & APAC.
• Lead transfer plans with timelines, milestones, documentation, and readiness criteria.
• Review transfer documentation and align with R&D/QC on acceptance criteria and standards.
• Provide expert troubleshooting and data-driven guidance across method development, validation, transfer and implementation.
• Lead complex, multi-site transfer workstreams and risk assessments; drive investigations and remediation.
• Collaborate with R&D, QC, QA, RA, and other network partners to ensure smooth transfer execution.

Conocimientos

Bioanalytical methods

GxP compliance

Immunoassays

Cell-based assays

Statistical analysis

Project management

Cross-functional collaboration

Regulatory knowledge

Educación

Bachelor’s or Master’s in Biological 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

• 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 distance of Salamanca, or willing to relocate.

Why Join Us?

For over 130 years, we have pioneered groundbreaking science. Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology. Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence. Because when it comes to animal health, no one sees it like we do.

Required Skills

Analytical Problem Solving, cGMP Compliance, Data Analysis, Inventory Management, Lean Six Sigma Continuous Improvement, Manufacturing Technologies, Process Improvements, Process Optimization, Production Planning, Production Scheduling, Vaccine Manufacturing

Employee Status

Regular

Flexible Work Arrangements

Not Applicable

Job Posting End Date

10/5/2026

• A job posting is effective until 11 59 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R400419