Merck
USA Nebraska Elkhorn, NE
Shift: Full time
Job Description Join Us in Shaping the Future of Animal Health 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. As a Methods Specialist, you will be part of a world-class team, contributing directly to the production and testing of veterinary products that improve animal health and welfare globally. You will collaborate closely with Quality Control, Manufacturing Operations, Bioprocess Technology Solutions, Regulatory Affairs, Statistics, and Analytical Technology Solutions across US sites to align priorities, expectations and deliverables. 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. Key Responsibilities: Support complex data analysis and trending to identify non-robust or out-of-specification methods. Conduct biomaterials assessments, inventory reviews, and document gap analyses to define remediation actions. Perform bench-level remediation across multiple test platforms, including live bacterial and virus titration/identification and ELISA for complex multivalent vaccines and in-process materials, working under guidance from senior team members. Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval with oversight from senior staff; update internal and regulatory procedures as required. Support post-remediation activities such as change control assessments and verification of sustained method performance. Participate in or lead cross-functional teams for site-to-site analytical method transfers: establish transfer plans, assess site readiness, and manage timelines, risks and deliverables with support from senior team members. Perform gap assessments of site capabilities – technical expertise, instrumentation, and laboratory operations — and implement remediation or training plans to ensure successful transfer and ongoing performance. Provide hands-on training during transfers (technical execution, assay operation, instrumentation use) and oversee transfer documentation protocols, validation reports and supporting documents. Support or lead post-transfer monitoring and hypercare to confirm method robustness and to resolve residual issues. Use internal project management systems to track progress, manage risks and report metrics with guidance from senior team members. Present technical updates, findings and recommend risk mitigations at team and regional meetings as needed. Education Minimum Requirement: Bachelor’s Degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science. Required Experience and Skills: Minimum 4 years of bench-level experience with an emphasis on Quality Control in vitro bioassay development for complex animal health vaccines; experience writing protocols and validation reports. Minimum 4 years of bioassay data analysis, trending and interpretation. Demonstrated familiarity with USDA regulations and requirements. Developing subject matter expertise in at least one bioassay platform (e.g. ELISA, virus titration, HA/HI) and proven ability to troubleshoot across multiple platforms. Developing skill sets in bioassay data analysis, trending and interpretation. Strong technical writing skills with experience preparing validation protocols and reports, and regulatory documentation for USDA review. Effective communication and presentation skills. Preferred Experience and Skills: Experience in bioassay experimental design and statistical interpretation. Experience designing methods to meet USDA regulatory expectations. Familiarity with analytical technologies such as imagers and liquid handlers. Experience presenting technical results to cross-functional stakeholders GAHM-ILC Required Skills: Adaptability, Assay, BioAssay, Bioassay Development, Cell Cultures, cGMP Compliance, Computer Literacy, Laboratory Operations, Laboratory Techniques, Product Knowledge, Protocol Writing, Validation Protocols Preferred Skills: Regulatory Submissions, Technical Writing, Validation Reports Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protec