Biomaterials Program Lead

The Biomaterials Program Lead will provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing. This role is responsible for biomaterials knowledge management, inventory and reorder strategy, replacement sourcing, equivalence qualification, method remediation, QC transfer support, and preparation of USDA-ready technical reports.

• Lead biomaterials knowledge management, including documentation of production history, characterization, inventory status, qualification status, and method dependencies.
• Manage biomaterials inventory strategy, including reorder levels, usage trends, lead times, expiry risks, and replacement triggers.
• Lead replacement biomaterials planning through outsourcing, commercial vendors, and internal sourcing options.
• Design, coordinate, and document equivalence qualification studies for replacement biomaterials to support USDA approval.
• Lead or support method remediation when biomaterial changes or performance issues impact biological test methods.
• Coordinate transfer of biomaterials and remediated methods to QC laboratories, ensuring documentation and readiness expectations are met.
• Prepare technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA review.
• Partner cross-functionally with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers.

• Bachelor’s degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a closely related discipline.
• Minimum of 7 years of experience in USDA-regulated animal health biologics.
• Minimum of 5 years of experience qualifying and preparing biomaterials-related technical documentation for regulatory review.
• Subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems.
• Strong technical writing skills with the ability to prepare clear, science-based, regulator-ready reports and justifications.

• Experience working with USDA.
• Experience with regulated quality systems.
• Experience with method validation and transfer.
• Experience collaborating across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external organizations.

Adaptability, Analytical Method Transfer, Animal Health Care, Bio Assay, Biological Assessments, Biologics, Biomaterials, Bioproduction, Cross-Functional Teamwork, Leadership, Method Development, Method Validation, Microbiological Test, Quality Control (QC), Technical Problem-Solving, Test Method Validation, USDA Regulations

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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