Associate Methods Specialist
Merck
August 19, 2026
Remote friendly (Omaha, NE)
United States
Operations
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.
Education Minimum:
- Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
Required Experience/Skills:
- 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.
Preferred:
- Troubleshooting methods for complex vaccines/in-process materials; experimental design knowledge; familiarity with imagers/liquid handlers; experience presenting results.
Benefits/Application:
- 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.
- Apply via https://jobs.merck.com/us/en (deadline stated on posting; effective until 11:59:59PM the day before 09/01/2026).
- 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.
Education Minimum:
- Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
Required Experience/Skills:
- 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.
Preferred:
- Troubleshooting methods for complex vaccines/in-process materials; experimental design knowledge; familiarity with imagers/liquid handlers; experience presenting results.
Benefits/Application:
- 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.
- Apply via https://jobs.merck.com/us/en (deadline stated on posting; effective until 11:59:59PM the day before 09/01/2026).