Program Lead - Method Remediation; Animal Health

Key Responsibilities

• Lead 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.
• Provide technical leadership and perform bench-level remediation across multiple test platforms, including live bacterial and viral titration/identification and ELISA for complex multivalent vaccines and in-process materials.
• Serve as a subject matter expert and senior troubleshooter; coach and support technical team members through remediation execution.
• Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal and regulatory procedures as required.
• Lead post-remediation activities, including subject matter export role in change control assessments.
• Guide biomaterials replacement and qualification activities as needed.
• Lead cross-functional site-to-site analytical method transfers: establish transfer plans, assess site readiness, and manage timelines, risks, and deliverables.
• Perform gap assessments of site capabilities (technical expertise, instrumentation, laboratory operations) and implement remediation or training plans.
• Provide hands-on training during transfers and oversee transfer documentation (protocols, validation reports, supporting documents).
• Lead post-transfer monitoring and hypercare support to confirm method robustness and resolve residual issues.
• Use internal project management systems to track progress, manage risks, and report metrics.
• Present project updates, technical findings, and risk mitigation plans at local, regional, and global forums.

• Education:
  
  Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
• Required experience/skills:
  • 7+ years bench-level QC method development, validation, and troubleshooting in vitro bioassays for complex animal health vaccines; proven ability writing protocols and validation reports.
  • 5+ years bioassay data analysis, trending, and interpretation.
  • Familiarity with USDA regulations.
  • Project management experience delivering analytical method development, remediation, and transfer projects (including reactive investigations).
  • Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) and proven ability to troubleshoot across multiple platforms.
  • Ability to lead cross-functional collaborations (Quality, Manufacturing, Regulatory, R&D) and manage multi-site projects.
  • Strong technical writing; excellent communication and presentation skills.

• Expertise in bioassay experimental design and statistical interpretation.
• Familiarity with analytical technologies (e.g., digital imagers, liquid handlers).
• People management experience developing technical talent.
• Track record presenting data and recommendations to cross-functional stakeholders.

• Bio Assay
• Biologics
• Driving Continuous Improvement
• ELISA Test
• Leadership
• Manufacturing Quality Control
• Process Improvements
• Regulatory Compliance
• Teamwork
• Technical Problem-Solving
• Titration Technique
• USDA Regulations