Associate Director, Quality Control

* **Serve as a primary ATS liaison for 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. Aligns site-level goals with broader organizational strategies and global analytical capabilities.* **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.* PhD or DVM in pharmacology, toxicology, chemistry, veterinary medicine, biology, or related biomedical sciences with **7+ years** of relevant industry experience;* **OR** Master’s degree with **9+ years** of experience;* **OR** Bachelor's degree with **10+ years** of experience.* **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.**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr