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.
• Act as a subject matter expert and senior troubleshooter; coach and support technical team members through remediation execution.
• Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval; update internal and regulatory procedures as required.
• Lead post‑remediation activities, including subject‑matter export role in change control assessments; may guide biomaterials replacement and qualification.
• 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 and implement remediation or training plans to ensure successful transfer and ongoing performance.
• 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.

• Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science.
• Minimum 7 years bench‑level Quality Control method development, validation and troubleshooting (in vitro bioassays for complex animal health vaccines); strong history of writing protocols and validation reports.
• Minimum 5 years bioassay data analysis, trending and interpretation.
• Familiarity with USDA regulations and requirements.
• 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 ability to troubleshoot across multiple platforms.
• Ability to lead cross‑functional collaborations across Quality, Manufacturing, Regulatory and R&D; manage projects across multiple sites.
• Strong technical writing skills for USDA protocols, validation reports and regulatory documentation.
• Excellent communication and presentation skills to senior leadership.

• 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

Apply via  (or via the Workday Jobs Hub if a current employee). Final date to receive applications is stated on the posting.

R392782