Associate Methods Specialist
$71,900–$113,200 year
HybridDe Soto, Kansas, United States or Elkhorn, Nebraska, United States
Job Summary
Conduct complex data analysis and trending to identify non-robust or out-of-specification methods, then perform bench-level remediation for live bacterial, virus titration, and ELISA assays. Author method remediation protocols, validation reports, and regulatory submissions for USDA review, while supporting post-remediation change control assessments and verifying sustained method performance. Lead cross-functional teams for site-to-site analytical method transfers, coordinating timelines, managing risks, and providing hands-on training on technical execution and instrumentation use.
Required Qualifications
- Bachelor's Degree in Biology, Genetics, Immunology, Microbiology, Virology, or a related biological science
- 1-3 years hands-on bench experience with an emphasis on in vitro bioassay development, testing and troubleshooting
- 1-3 years of experience in animal health environments (Quality Control, R&D and/or Technical Support)
- familiarity with USDA regulations and requirements
- Developing subject matter expertise in at least one bioassay platform (e.g. ELISA, virus titration, HA/HI)
- Developing skill sets in bioassay data analysis, trending and interpretation
- Strong technical writing skills with ability to learn how to prepare protocols, reports and related laboratory documentation
- Effective communicator with experience collaborating across functions
- Analytical Problem Solving
- Bioinformatics
- Biology
- Biomedical Sciences
- Business Process Improvements
- Change Management
- Cost Efficiency
- Data Trends
- Document Management
- Enzyme Linked Immunosorbent Assay (ELISA)
- Equipment Maintenance
- Equipment Set Up
- Good Manufacturing Practices (GMP)
- In Vitro Research
- Laboratory Instrumentation
- Laboratory Operations
- Laboratory Techniques
- Machinery Operation
- Manufacturing Operations
- Performance Monitoring
- Process Analytics
- Process Improvements
- Process Optimization
- Production Planning
- Valid Driving License
Desired Qualifications
- Experience performing or troubleshooting analytical methods for complex animal health vaccines and in-process materials
- Capability to learn how to design and develop methods to meet USDA regulatory expectations
- Practical knowledge of bioassay experimental design
- Familiarity with analytical technologies such as imagers and liquid handlers
- Experience presenting technical results to cross-functional stakeholders
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