Biomaterials Methods Specialist — Regulatory & QC

MSD Malaysia; De Soto (KS); Hybrid; USD 79,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation time

Sick days

Job summary

Merck Animal Health in the United States seeks a Methods Specialist to support biomaterials management, method remediation, and regulatory documentation for USDA-regulated biologics. This role ensures inventory, documentation, and collaboration with QA, Regulatory Affairs, R&D, and external suppliers.

The position requires a Bachelor’s in biological sciences and at least 5 years of experience with USDA-regulated biologics, with expertise in immunoassays or cell-based methods and strong technical

Qualifications

• Bachelor’s degree in biological sciences or closely related field.
• Minimum 5 years’ experience with USDA-regulated animal health biologics.
• Strong scientific writing and documentation skills.

Responsibilities

• Maintain biomaterials documentation and production history.
• Monitor biomaterials inventory and expiry risks.
• Support biomaterials replacement planning and equivalence qualification.
• Assist with method remediation when biomaterials affect performance.
• Support transfer to QC laboratories.
• Draft technical reports and regulatory support documents.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers.

Skills

Biomaterials management

Regulatory documentation

USDA-regulated biologics

Immunoassays

Cell-based methods

Technical writing

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s degree in biological sciences

Job description

Merck Animal Health in the United States seeks a Methods Specialist to support biomaterials management, method remediation, and regulatory documentation for USDA-regulated biologics. This role ensures inventory, documentation, and collaboration with QA, Regulatory Affairs, R&D, and external suppliers.

The position requires a Bachelor’s in biological sciences and at least 5 years of experience with USDA-regulated biologics, with expertise in immunoassays or cell-based methods and strong technical