Associate Methods Specialist

Role Responsibilities:

• Support complex data analysis and trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and gap analyses.
• Perform bench-level remediation across test platforms (live bacterial/virus titration & identification; ELISA for complex 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 assessments and verification of sustained method performance.
• Participate in/lead cross-functional site-to-site analytical method transfer projects; coordinate timelines/deliverables.
• Assess site capabilities (skills, instrumentation, lab operations) and implement remediation/training plans.
• Provide hands‑on training during transfers and oversee transfer documentation/validation reports.
• Support post‑transfer monitoring to confirm robustness and resolve residual issues.
• Track progress, manage risks, and report metrics using internal systems; present updates and risk mitigations.

• Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.

• 1–3 years hands‑on bench experience in in‑vitro bioassay development/testing/troubleshooting.
• 1–3 years in animal health environments (QC, R&D, and/or Technical Support) with familiarity with USDA requirements.
• Expertise in at least one bioassay platform (ELISA, virus titration, HA/HI); data analysis/trending.
• Strong technical writing; effective cross‑functional communicator.

• Troubleshooting methods for complex vaccines/in‑process materials; experimental design knowledge; familiarity with imagers/liquid handlers; experience presenting results.

• Eligible for annual bonus and long‑term incentive (if applicable); comprehensive benefits including medical/dental/vision, retirement (401(k)), paid holidays, vacation, and sick/compassionate days.