Biomaterials Program Lead
Core
Provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing.
Role type
Senior Program Lead, Biomaterials Lifecycle Management
Builds
Supports USDA-ready biologics production and testing capabilities
Domain
Animal Health / Biologics Manufacturing
Required skills
Biomaterials Lifecycle Management, Equivalence Qualification, Method Remediation, Regulatory Documentation, Inventory Strategy, Cross-Functional Leadership, Technical Writing, Biological Method Expertise, USDA Regulations, Quality Control Transfer
Preferred skills
USDA Experience, Regulated Quality Systems, Method Validation, Cross-Functional Collaboration
Technologies
Immunoassays, Cell-based methods, Biological test systems
Responsibilities
Lead biomaterials knowledge management and documentation; Manage inventory strategy including reorder levels and expiry risks; Lead replacement biomaterials planning and equivalence qualification studies; Coordinate method remediation and transfer to QC laboratories; Prepare technical reports and regulatory support documents for USDA review; Partner with Manufacturing, QC, QA, Regulatory Affairs, and R&D.
Seniority
Senior, hands-on IC with program leadership
