Senior Specialist, Method Transfers

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

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:

• 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.

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

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.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.