Methods Specialist
Merck
8 days ago
Remote friendly (Millsboro, DE)
United States
Operations
Key Responsibilities
- Support complex data analysis and trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and document gap analyses.
- Perform bench-level remediation across test platforms (live bacterial/virus titration & identification; ELISA for complex multivalent vaccines/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 performance.
- Lead/support cross-functional site-to-site analytical method transfers (transfer plans, readiness assessment, manage timelines/risks/deliverables).
- Conduct site capability gap assessments and implement remediation/training plans.
- Provide hands-on training during transfers and oversee transfer documentation and validation materials.
- Support post-transfer monitoring/hypercare to confirm robustness and resolve residual issues.
- Use project management systems to track progress, manage risks, report metrics; present updates and risk 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.
- Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) and ability to troubleshoot across platforms.
- Strong technical writing; effective communication and presentation.
Preferred Experience/Skills
- Experimental design and statistical interpretation; designing methods to meet USDA expectations.
- Familiarity with imagers and liquid handlers.
- Presenting technical results to cross-functional stakeholders.
Required Skills (examples)
- Assay/Bioassay development, cGMP compliance, laboratory operations/techniques, protocol writing, validation protocols, computer literacy.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Support complex data analysis and trending to identify non-robust or out-of-specification methods; conduct biomaterials assessments, inventory reviews, and document gap analyses.
- Perform bench-level remediation across test platforms (live bacterial/virus titration & identification; ELISA for complex multivalent vaccines/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 performance.
- Lead/support cross-functional site-to-site analytical method transfers (transfer plans, readiness assessment, manage timelines/risks/deliverables).
- Conduct site capability gap assessments and implement remediation/training plans.
- Provide hands-on training during transfers and oversee transfer documentation and validation materials.
- Support post-transfer monitoring/hypercare to confirm robustness and resolve residual issues.
- Use project management systems to track progress, manage risks, report metrics; present updates and risk 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.
- Subject matter expertise in at least one bioassay platform (e.g., ELISA, virus titration, HA/HI) and ability to troubleshoot across platforms.
- Strong technical writing; effective communication and presentation.
Preferred Experience/Skills
- Experimental design and statistical interpretation; designing methods to meet USDA expectations.
- Familiarity with imagers and liquid handlers.
- Presenting technical results to cross-functional stakeholders.
Required Skills (examples)
- Assay/Bioassay development, cGMP compliance, laboratory operations/techniques, protocol writing, validation protocols, computer literacy.
Application Instructions
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.