Methods Specialist
Merck
8 days ago
Remote friendly (Omaha, NE)
United States
Clinical Research and Development
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.
Education:
- Bachelor’s degree in Biology/Genetics/Immunology/Microbiology/Virology or related biological science.
Required Experience & Skills:
- 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.
Preferred:
- Bioassay experimental design & statistical interpretation; designing methods for USDA expectations.
- Familiarity with imagers and liquid handlers; present results to cross-functional stakeholders.
Benefits (explicitly stated):
- Annual bonus/long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).
- 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.
Education:
- Bachelor’s degree in Biology/Genetics/Immunology/Microbiology/Virology or related biological science.
Required Experience & Skills:
- 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.
Preferred:
- Bioassay experimental design & statistical interpretation; designing methods for USDA expectations.
- Familiarity with imagers and liquid handlers; present results to cross-functional stakeholders.
Benefits (explicitly stated):
- Annual bonus/long-term incentive (if applicable); comprehensive medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).