Methods Specialist
Core
Maintain biomaterials documentation, monitor inventory, support replacement and equivalence qualification, and prepare technical documentation for regulatory review of USDA-regulated animal health biologics.
Role type
Methods Specialist (Regulatory & Quality Systems)
Builds
Regulatory submissions and qualification packages for veterinary biologics
Domain
Animal Health / Biologics / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biomaterials management, Method remediation, Method validation, Method transfer, Technical writing, Inventory monitoring, Qualification activities, Regulatory documentation, cGMP compliance, Data analysis
Preferred skills
CVB submission experience, Regulated quality systems, Cross-functional collaboration, External supplier management
Technologies
Immunoassays, Cell-based methods, Column chromatography, Equipment setup
Responsibilities
Maintain biomaterials documentation including production history and qualification status; Monitor inventory usage trends and expiry risks; Support biomaterials replacement planning and equivalence qualification; Assist with method remediation when biomaterials impact performance; Support transfer of methods to QC laboratories; Draft technical reports and regulatory support documents for USDA or CVB review.
Seniority
Mid-Senior level, hands-on IC
