Biomaterials Program Lead: USDA-Ready Biologics

HireLifeScience; De Soto (KS); Hybrid; USD 129,000 - 203,000; Full time

Benefits offered by this job

Health insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Job summary

HireLifeScience seeks a Biomaterials Program Lead to drive lifecycle management of critical biomaterials used in animal health biologics, including knowledge management, inventory, and USDA-ready reporting.

You will lead equivalence studies, remediation efforts, and cross-functional coordination with Manufacturing, QC, QA, Regulatory Affairs, R&D, and suppliers to ensure regulatory readiness and high-quality science.

Qualifications

• Bachelor's degree in a biological science and extensive regulatory experience.
• Minimum of 7 years in USDA-regulated animal health biologics.
• Minimum of 5 years qualifying biomaterials documentation for regulatory review.
• Subject matter expertise in at least one biological method platform.
• Strong technical writing for regulator-ready reports and justifications.

Responsibilities

• Lead biomaterials knowledge management including production history and qualification status.
• Manage biomaterials inventory strategy, lead times, expiry risks and reorders.
• Coordinate replacement biomaterials planning via outsourcing or internal sourcing.
• Design and document equivalence qualification studies for USDA approval.
• Lead or support method remediation when biomaterial changes impact tests.
• Coordinate transfer of biomaterials and remediated methods to QC labs.
• Prepare technical reports and regulatory support documents for USDA review.
• Partner 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

USDA Regulations

Education

Bachelor's degree in Biological Science

Job description

HireLifeScience seeks a Biomaterials Program Lead to drive lifecycle management of critical biomaterials used in animal health biologics, including knowledge management, inventory, and USDA-ready reporting.

You will lead equivalence studies, remediation efforts, and cross-functional coordination with Manufacturing, QC, QA, Regulatory Affairs, R&D, and suppliers to ensure regulatory readiness and high-quality science.