Associate Methods Specialist

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.

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

• 1–3 years bench experience in in vitro bioassay development/testing/troubleshooting.
• 1–3 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.

• Experience troubleshooting analytical methods for complex vaccines/in-process materials; bioassay experimental design; analytical tech (imagers, liquid handlers); presenting results to stakeholders.

• Salary range: $71,900–$113,200; eligible for annual bonus/long-term incentive (if applicable). Benefits include medical/dental/vision, 401(k), paid holidays/vacation, and sick/compassionate days.