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 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 hyper-care 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 a related biological science.

• Minimum 7 years bench-level Quality Control method development, validation and troubleshooting for in vitro bioassays for complex animal health vaccines; strong history 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) with proven troubleshooting across multiple platforms.
• Proven ability to lead cross-functional collaborations across Quality, Manufacturing, Regulatory and R&D; manage multi-site projects.
• Strong technical writing; prepare protocols, validation reports and regulatory documentation for USDA review.
• Excellent communication/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/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 Workday Jobs Hub if a current employee). Final date to receive applications is stated on the posting. Requisition : R392782.