Biomaterials Program Lead - USDA-Regulated Biologics

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

Job summary

Merck & Co., Inc. seeks a Biomaterials Program Lead to provide technical and program leadership for biomaterials used in animal health biologics.

Responsibilities include knowledge management, inventory strategy, replacement sourcing, equivalence qualification, and regulatory reporting for USDA review. Experience in at least one biological method platform, strong technical writing, and collaboration across Manufacturing, QC, QA, Regulatory Affairs, R&D, and suppliers are essential.

Qualifications

• Bachelor’s degree in a biological science or 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 or cell-based methods.

Responsibilities

• Lead biomaterials knowledge management including documentation of production history, characterization, inventory status, and qualification status.
• Manage biomaterials inventory strategy including reorder levels, usage trends, lead times, expiry risks, and replacement triggers.
• Lead replacement biomaterials planning through outsourcing, vendors, and internal sourcing options.
• Coordinate equivalence qualification studies to support USDA approval.
• Support method remediation when biomaterial changes impact test methods.
• Prepare technical reports, qualification summaries, and regulatory support documents for USDA review.

Skills

Leadership

Biomaterials

Cross-Functional Teamwork

Method Development

Technical Writing

Biological Assays

Education

Bachelor’s in Biological Science

Job description

Merck & Co., Inc. seeks a Biomaterials Program Lead to provide technical and program leadership for biomaterials used in animal health biologics.

Responsibilities include knowledge management, inventory strategy, replacement sourcing, equivalence qualification, and regulatory reporting for USDA review. Experience in at least one biological method platform, strong technical writing, and collaboration across Manufacturing, QC, QA, Regulatory Affairs, R&D, and suppliers are essential.