Biomaterials Program Lead: Animal Health Biologics

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

Benefits offered by this job

Medical insurance

Retirement benefits

Paid holidays

Job summary

Merck is seeking a Biomaterials Program Lead to provide scientific and program leadership for lifecycle management of critical biomaterials used in animal health biologics. Responsibilities include knowledge management, inventory strategy, sourcing, equivalence qualification, method remediation, and regulatory support for USDA review.

The role requires collaboration across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers, with a focus on regulator-ready reports and

Qualifications

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

Responsibilities

• Lead biomaterials knowledge management and inventory status.
• Manage biomaterials inventory strategy, lead times, expiry risks, replacement triggers.
• Plan replacement biomaterials through outsourcing and internal sourcing.
• Coordinate equivalence qualification studies for USDA approval.
• Support method remediation when biomaterial changes impact tests.
• Coordinate biomaterials transfer to QC labs with proper documentation.
• Prepare technical reports and regulatory support documents for USDA review.
• Partner across Manufacturing, QC, QA, Regulatory Affairs, R&D and suppliers.

Skills

Biomaterials

Regulatory knowledge

Documentation

Leadership

Project management

Quality systems

Cross-functional teamwork

Technical writing

Education

Bachelor's degree in Biological Sciences

Job description

Merck is seeking a Biomaterials Program Lead to provide scientific and program leadership for lifecycle management of critical biomaterials used in animal health biologics. Responsibilities include knowledge management, inventory strategy, sourcing, equivalence qualification, method remediation, and regulatory support for USDA review.

The role requires collaboration across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers, with a focus on regulator-ready reports and