Methods Specialist
Merck
9 days ago
Remote friendly (De Soto, KS)
United States
Other
Key Responsibilities:
- Support complex data analysis and trending to identify non-robust or out-of-specification methods; perform biomaterials assessments, inventory reviews, and gap analyses to define remediation actions.
- Perform bench-level remediation across test platforms (e.g., live bacterial/virus titration & identification; ELISA for multivalent vaccines and in-process materials) under senior guidance.
- Author method remediation protocols, validation reports, and USDA regulatory submissions (with senior oversight); update internal and regulatory procedures.
- Support change control assessments; verify sustained method performance.
- Participate in/lead analytical method transfers across sites (transfer plans, site readiness, timelines, risks, deliverables).
- Conduct site capability gap assessments (expertise, instrumentation, lab operations) and implement remediation/training.
- Provide hands-on transfer training; oversee transfer documentation and validation reporting.
- Support/lead post-transfer monitoring and hypercare; use project management systems to track risks/metrics.
- Present technical updates and recommend risk mitigations.
Education:
- Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
Required Experience/Skills:
- 4+ years bench experience in 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 ability to troubleshoot across platforms.
- Strong technical writing; effective communication/presentation.
Preferred Experience/Skills:
- Bioassay experimental design and statistical interpretation.
- USDA-compliant method design.
- Analytical tech familiarity (imagers, liquid handlers).
- Presenting results to cross-functional stakeholders.
Required Skills (examples): Adaptability; Bioassay/Bioassay Development; cGMP compliance; laboratory operations/techniques; protocol writing; validation protocols; computer literacy.
Benefits (explicitly stated): Medical/dental/vision insurance, retirement/401(k), paid holidays, vacation, and compassionate/sick days; annual bonus and long-term incentive (if applicable).
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Apply by the posting deadline shown on the posting; Requisition ID: R392787.
- Support complex data analysis and trending to identify non-robust or out-of-specification methods; perform biomaterials assessments, inventory reviews, and gap analyses to define remediation actions.
- Perform bench-level remediation across test platforms (e.g., live bacterial/virus titration & identification; ELISA for multivalent vaccines and in-process materials) under senior guidance.
- Author method remediation protocols, validation reports, and USDA regulatory submissions (with senior oversight); update internal and regulatory procedures.
- Support change control assessments; verify sustained method performance.
- Participate in/lead analytical method transfers across sites (transfer plans, site readiness, timelines, risks, deliverables).
- Conduct site capability gap assessments (expertise, instrumentation, lab operations) and implement remediation/training.
- Provide hands-on transfer training; oversee transfer documentation and validation reporting.
- Support/lead post-transfer monitoring and hypercare; use project management systems to track risks/metrics.
- Present technical updates and recommend risk mitigations.
Education:
- Bachelor’s degree in Biology, Genetics, Immunology, Microbiology, Virology, or related biological science.
Required Experience/Skills:
- 4+ years bench experience in 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 ability to troubleshoot across platforms.
- Strong technical writing; effective communication/presentation.
Preferred Experience/Skills:
- Bioassay experimental design and statistical interpretation.
- USDA-compliant method design.
- Analytical tech familiarity (imagers, liquid handlers).
- Presenting results to cross-functional stakeholders.
Required Skills (examples): Adaptability; Bioassay/Bioassay Development; cGMP compliance; laboratory operations/techniques; protocol writing; validation protocols; computer literacy.
Benefits (explicitly stated): Medical/dental/vision insurance, retirement/401(k), paid holidays, vacation, and compassionate/sick days; annual bonus and long-term incentive (if applicable).
Application:
- Apply via https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Apply by the posting deadline shown on the posting; Requisition ID: R392787.