Methods Specialist

Merck Merck · Pharma · NE

This role focuses on the development, testing, and validation of analytical methods for veterinary products, involving complex data analysis, bench-level remediation, and authoring regulatory submissions for USDA review. It requires collaboration across various departments and sites to ensure method robustness and successful transfer.

What you'd actually do

  1. Support complex data analysis and trending to identify non-robust or out-of-specification methods. Conduct biomaterials assessments, inventory reviews, and document gap analyses to define remediation actions.
  2. Perform bench-level remediation across multiple test platforms, including live bacterial and virus titration/identification and ELISA for complex multivalent vaccines and in-process materials, working under guidance from senior team members.
  3. Author method remediation protocols, validation reports, and regulatory submissions for USDA review and approval with oversight from senior staff; update internal and regulatory procedures as required.
  4. Support post-remediation activities such as change control assessments and verification of sustained method performance.
  5. Participate in or lead cross-functional teams for site-to-site analytical method transfers: establish transfer plans, assess site readiness, and manage timelines, risks and deliverables with support from senior team members.

Skills

Required

  • bench-level experience with an emphasis on Quality Control in vitro bioassay development for complex animal health vaccines
  • writing protocols and validation reports
  • bioassay data analysis, trending and interpretation
  • Demonstrated familiarity with USDA regulations and requirements
  • subject matter expertise in at least one bioassay platform (e.g. ELISA, virus titration, HA/HI)
  • troubleshoot across multiple platforms
  • bioassay data analysis, trending and interpretation
  • Strong technical writing skills
  • preparing validation protocols and reports
  • regulatory documentation for USDA review
  • Effective communication and presentation skills
  • cGMP Compliance
  • Data Analysis
  • Regulatory Compliance
  • Process Troubleshooting
  • Process Monitoring
  • Process Optimization
  • Equipment Set Up
  • Teamwork
  • Training and Development

Nice to have

  • bioassay experimental design
  • statistical interpretation
  • designing methods to meet USDA regulatory expectations
  • analytical technologies such as imagers and liquid handlers
  • presenting technical results to cross-functional stakeholders
  • Column Chromatography
  • Computer Literacy
  • Environmental Health and Safety (EHS) Management
  • Lean Manufacturing Tools
  • Visual Management
  • Adaptability

What the JD emphasized

  • USDA review and approval
  • USDA regulations and requirements
  • method remediation protocols
  • validation reports
  • analytical method transfers