Role Responsibilities
- Support complex data analysis/trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and document gap analyses for remediation.
- Perform bench-level remediation across test platforms (live bacterial/virus titration/identification; ELISA for multivalent vaccines and in-process materials).
- Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal/regulatory procedures.
- Support post-remediation change control and verification of sustained method performance.
- Participate/lead cross-functional site-to-site analytical method transfers; coordinate timelines/deliverables.
- Assess site capabilities (skills, instrumentation, lab operations) and implement remediation/training plans.
- Provide hands-on training during transfers and oversee transfer/validation documentation.
- Support post-transfer monitoring to confirm robustness and resolve residual issues.
- Use internal project systems to track progress, manage risks, and report metrics; present updates and recommend risk mitigations.
Education
- Bachelorβs degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
Required Experience/Skills
- 1β3 years bench experience in in vitro bioassay development/testing/troubleshooting.
- 1β3 years in animal health QC/R&D/technical support; familiarity with USDA regulations.
- Expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) plus data analysis/trending/interpretation.
- Strong technical writing; effective cross-functional communication.