Methods Specialist

Key Responsibilities

• Support complex data analysis/trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and gap analyses to define remediation.
• Perform bench-level remediation across test platforms (live bacterial/virus titration/identification and ELISA for multivalent vaccines and in-process materials) under senior guidance.
• Author method remediation protocols, validation reports, and USDA regulatory submissions; update internal/regulatory procedures.
• Conduct post-remediation change control assessments and verify sustained method performance.
• Lead site-to-site analytical method transfers (transfer plans, site readiness, timelines/risks/deliverables).
• Assess site capabilities and implement remediation/training for successful transfer and ongoing performance.
• Provide hands‑on training during transfers; oversee transfer documentation, validation reports, and supporting documents.
• Support post-transfer monitoring/hypercare to confirm robustness and resolve residual issues.
• Use project management systems to track progress, manage risks, and report metrics; present updates and recommend mitigations.

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

• 4+ years bench-level QC in vitro bioassay development for complex animal health vaccines; protocol/validation report writing.
• 4+ years bioassay data analysis, trending, and interpretation.
• Familiarity with USDA regulations.
• Expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) and troubleshooting across platforms.
• Strong technical writing; effective communication/presentation.

• Bioassay experimental design & statistical interpretation; designing methods for USDA expectations.
• Familiarity with imagers and liquid handlers; present results to cross‑functional stakeholders.

• Annual bonus/long‑term incentive (if applicable); comprehensive medical/dental/vision.
• Retirement (401(k)).
• Paid holidays/vacation.
• Compassionate and sick days.

Apply at  (deadline stated on posting).