Senior Method Transfer Specialist (Bioassays)

Job description

Job Description Act at the interface of R&D and QC and use your commercial pharma experience to support robust method transfers, minimize supply risk, and support on-time product releases. For our Animal Health location Boxmeer, we are currently recruiting a Senior Method Transfer Specialist (Bioassays) Welcome to our team 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 in transfers to our manufacturing site in Salamanca (Spain), we are looking for a Senior Method Transfer Specialist (Bioassays). Purpose of the role In this newly created role, you will serve as a strategic partner and subject matter expert in the coordination and execution of ATS-Large Molecule analytical transfer priorities. You will lead and support the planning, organization, and coordination of analytical method transfers to meet business goals and customer needs. You will collaborate closely with R&D teams, providing expert advice and support in the development of robust bio-analytical methods during the pre-development and development phases of new product commercialization (NPC) programs into our manufacturing site in Salamanca, Spain. Your involvement in assay problem-solving and transfer readiness will ensure smooth and efficient analytical method transfers between R&D and QC sites, fostering alignment and mutual understanding. Additionally, you follow the change control process to ensure any product changes after method validation are checked for impact and any required corrective actions. Main tasks and responsibilities ·       Act as sparring partner for R&D during early assay development, providing definitive input on method robustness, platform suitability, biomaterials and QC feasibility to enable right-first-time method transfers and reliable batch release testing ·       Prepare and execute the transfer plan for assigned methods (timelines, milestones, documentation, and transfer readiness criteria) with responsibility for resource & cost planning at the project level ·       Lead risk/gap assessments and prepare/review transfer documentation (protocols, reports) ·       Aligning with R&D and QC stakeholders on method readiness, acceptance criteria, specification settings, documentation standards, and coordinated execution ·       Serve as SME for LM bioanalytical methods, providing expert troubleshooting, data‑driven analytical advice, and technical guidance during method development, improvement, validation, transfer and implementation ·       Lead complex or multi‑site transfer workstreams, coordinate cross-functional activities, and drive technical investigations and remediation actions required to ensure robust assay performance ·       Perform and interpret advanced data analyses and statistical evaluations (e.g., robustness trending, method performance assessment, hypothesis testing) to support method readiness and successful implementation at QC sites ·       Contribute to analytical lifecycle maturity through active participation in robustness initiatives, remediation programs, harmonization efforts, and knowledge‑sharing across ATS and QC laboratories ·       Build strong relationships with R&D, QC, QA, RA, BTS, Data Science, and other network partners, facilitating alignment across functions with differing perspectives and priorities ·       Provide clear, timely communication and escalate issues when needed to support risk management and decision‑making at project and governance points such as NPDP stage gates ·       Provide input to departmental strategy related to method transfers, make decisions within guidelines for assigned programs, and propose changes that impact analytical transfer strategies Your profile A completed Bachelor of Applied Science (BSc) or Master of Science (MSc) degree in Biochemistry, Biology, Molecular Biology, or a related field. Extensive hands-on experience, combined with deep technical expertise in large molecule biological QC methods (e.g., ELISA, PCR, cell culture, virus titration, and other relevant bio-analytical techniques), including development, validation, transfer, and troubleshooting/remediation to ensure robust assay performance. Proven experience working within commercial pharmaceutical manufacturing environments, including familiarity with GMP production workflows, batch release processes, and QC release timelines to ensure timely method transfers that support product launch and supply continuity. Strong data analysis skills, including extensive experience with statistical software (e.g., Minitab, Aera), and a demonstrated ability to identify root causes and implement effective solutions. Strong project management skills and proven experience leading complex cross-functional analytical work packages independently, while fostering collaboration and alignment across multi-site organizations. Proven communication, negotiation and influencing skills to harmonize competing priorities while maintaining excellent cross-team relationships. Good command of the Spanish and English language. Dutch preferred. Based within a reasonable commuting distance of Boxmeer, as this position requires on-site presence for at least three days per week, or willing to relocate. Willing to travel to Salamanca (Spain) at least six times per year. What we offer The opportunity to play a key role in method transfers and product launches that affect the whole network, partnering closely with multidisciplinary teams to broaden your influence and expertise. In addition, we offer a competitive benefits package that supports your well-being, growth, and long-term success. ·       Competitive compensation aligned with your knowledge and experience. ·       3% year-end payment and an annual bonus based on individual and company performance. ·       35,5 days of leave. ·       Solid Pension Plan. ·       Travel allowance for commuting. ·       Numerous training, coaching and e-learning modules for long term job opportunities and development. ·       Excellent accessibility: the train station is right by our main entrance and there is ample parking. ·       High-quality company restaurant with fresh, healthy options daily. ·       Contribution toward your personal sports/fitness membership to support your vitality. ·       Beautiful private park on the premises, ideal for a walk, break, or moment of relaxation. ·       Mental well-being support via Lyra Health for you and your family members. ·       Access to a dedicated prayer/meditation room. Animal Health Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, whil