Associate Director, Analytical Technical Solutions (Animal Health)

Job Description US Analytical Technology Solutions (US-ATS) supports all Animal Health sites globally in analytical method development, improvement, validation, transfer and other analytical investigations. This position will lead and oversee all aspects of analytical life cycle management activities for in‑line licensed products and introduce new innovative analytical technologies. Primary Responsibilities Serve as a primary ATS liaison for the Millsboro Site (Site Lead), acting as the primary point of contact for Tier meetings and cross‑functional site‑level forums with BTS, Quality and other operational stakeholders. Provide strategic leadership to an analytical matrix team across multiple US sites to oversee biologics assay development, validation, transfer, improvement and implementation for viral and bacterial vaccines as well as other biotherapeutics. Lead the implementation, qualification and life‑cycle management of analytical methods supporting raw materials, drug substance and drug product testing. Develop, communicate and execute strategic plans aligned with portfolio and pipeline priorities to ensure timely, high‑quality analytical data delivery. Collaborate closely with cross‑functional partners including QC, R&D, Regulatory Affairs, Quality Assurance, Manufacturing and site functional leaders to drive integrated development and testing strategies. Ensure compliance with global regulatory expectations (EMA, VSM/VICH/USDA, USP, ICH, GLP, etc.) and contribute to regulatory submissions, inspections and dossier authoring. Provide scientific and analytical oversight for cGMP documentation, including change controls, deviations, CAPAs, method qualification/validation protocols and reports, method transfer documentation and specification justifications. Drive innovation by identifying, evaluating and implementing new technologies and analytical methodologies, including ligand‑binding assays, immune‑, molecular‑ and cell‑based assays. Interpret complex scientific data, troubleshoot analytical issues and develop scientifically sound solutions that meet program and regulatory requirements. Drive continuous improvement and operational excellence through standardization, data integrity initiatives, harmonized procedures and best practices across sites. Lead proactive resources and capacity planning to ensure alignment with development strategy and program timelines aligned with business priorities. Support primary and working reference standard and critical reagent management, including qualification, aliquoting and long‑term management across all end‑users of the materials. Education Requirements PhD or DVM in pharmacology, toxicology, veterinary medicine with 7+ years of relevant industry experience. OR Master's degree in pharmacology, toxicology, veterinary medicine with 9+ years of experience. OR Bachelor's degree in pharmacology, toxicology, veterinary medicine with 10+ years of experience. Required Experience and Skills Extensive knowledge of US, European and international veterinary drug development requirements for both companion and production animals. Proven leadership experience managing technical teams, laboratory operations and external partnerships or CRO collaborations. Deep expertise in bioanalytical techniques including ELISA, ligand‑binding assays, protein chemistry, molecular biology, immunoassays and cell‑based assay development for biologics and large molecules. Demonstrated experience with analytical method development, transfer, qualification, validation/co‑validation, transfer and continuous method improvement. Strong understanding of global regulatory requirements and experience supporting or authoring analytical sections in regulatory submissions for veterinary products. Ability to influence and lead cross‑functional teams, drive strategic initiatives and collaborate effectively in a matrixed environment. Strong project management skills, with experience managing multiple projects simultaneously across various stages of development. Excellent communication, organizational and problem‑solving abilities, with demonstrated success in technical leadership roles within the biotechnology or biopharmaceutical industry. Required Skills Analytical Method Development Analytical Problem Solving Analytical Thinking Biological Analysis Communication Continuous Improvement Tools Counterfeit Detection Cross‑Functional Teamwork Identifying Customer Needs Innovation Leadership Management Process Method Transfer Method Validation Microbiological Analysis People Management Quantitative Assay Regulatory Compliance Team Leadership Technical Transfer Veterinary Medicine Salary and Benefits Salary range: $129,000.00 – $203,100.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision healthcare and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation and compassionate and sick days. More information about benefits is available on our careers site. Equal Employment Opportunity We are an Equal Employment Opportunity Employer and provide equal opportunities to all employees and applicants for employment. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. #J-18808-Ljbffr