Biomaterials Program Lead for USDA-Regulated Biologics

HireLifeScience; Elkhorn Precinct (NE); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

HireLifeScience is seeking a Biomaterials Program Lead to provide technical and program leadership for the lifecycle management of biomaterials used in animal health biologics production and testing. Responsibilities include knowledge management, inventory strategy, replacement sourcing, equivalence qualification, and regulatory support.

The role requires extensive leadership experience across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers, with a strong emphasis on

Qualifications

• Bachelor's degree in a biological science required.
• 7+ years of experience in USDA-regulated animal health biologics.
• 5+ years of experience qualifying and preparing biomaterials-related technical documentation for regulatory review.
• Subject matter expertise in at least one biological method platform (immunoassays, cell-based methods, or other relevant biological test systems).
• Strong technical writing skills to prepare regulator-ready reports and justifications.

Responsibilities

• 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.

Skills

Adaptability

Analytical Method Transfer

Animal Health Care

BioAssay

Biological Assessments

Biological Testing

Biologics

Biomaterials

Bioproduction

Cross-Functional Teamwork

Leadership

Method Development

Method Validation

Microbiological Test

Quality Control (QC)

Technical Problem-Solving

Test Method Validation

USDA Regulations

Education

Bachelor's degree in Biological Science

Job description

HireLifeScience is seeking a Biomaterials Program Lead to provide technical and program leadership for the lifecycle management of biomaterials used in animal health biologics production and testing. Responsibilities include knowledge management, inventory strategy, replacement sourcing, equivalence qualification, and regulatory support.

The role requires extensive leadership experience across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers, with a strong emphasis on