Biomaterials Program Lead

About the role

The Biomaterials Program Lead provides technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing. This position oversees knowledge management, inventory strategy, replacement sourcing, and regulatory documentation.

Key responsibilities

• Lead biomaterials knowledge management, documenting production history, characterization, inventory status and qualification.
• Manage inventory strategy, including reorder levels, usage trends, expiry risks and replacement triggers.
• Design and coordinate equivalence qualification studies for replacement biomaterials to support USDA approval.
• Lead method remediation and coordinate transfer of biomaterials and remediated methods to QC laboratories.
• Prepare technical reports, qualification summaries and regulatory support documents for USDA review.

Required profile

• Bachelor’s degree in a biological science (e.g., Biology, Microbiology, Genetics, Virology).
• Minimum 7 years experience in USDA‑regulated animal health biologics.
• At least 5 years qualifying biomaterials and preparing technical documentation for regulatory review.
• Subject‑matter expertise in at least one biological method platform (immunoassays, cell‑based methods, etc.).
• Strong technical writing skills for regulator‑ready reports.

Required skills

• Biomaterials management
• USDA regulations
• Method validation
• Technical writing
• Inventory management

What we offer

• Salary range $129,000 – $203,100 per year
• Annual bonus and long‑term incentive eligibility
• Comprehensive benefits including medical, dental, vision, 401(k), paid holidays and vacation
• Hybrid work arrangement