Hybrid Biomaterials Methods Specialist

Merck; Omaha (NE); Hybrid; USD 79,000 - 125,000; Full time

Job summary

Merck is seeking a Methods Specialist in the United States to support biomaterials management and method remediation for USDA-regulated animal health biologics. Responsibilities include maintaining documentation, inventory monitoring, and assisting with regulatory reports, while collaborating with Manufacturing, QC, QA, Regulatory Affairs, R&D, and Supply Chain.

The role requires a biology-related bachelor's degree and at least five years of experience in regulated biologics, plus expertise in

Qualifications

• Bachelor’s degree in a biological science.
• Minimum of 5 years of experience in USDA-regulated animal health biologics, veterinary biologics.
• Developing subject matter expertise in at least one biological method platform, such as immunoassays, cell-based methods, or other relevant biological test systems.
• Strong scientific documentation and technical writing skills.

Responsibilities

• Maintain biomaterials documentation, including production history, characterization, inventory status, qualification status, and method dependencies.
• Monitor biomaterials inventory, usage trends, expiry risks, and reorder triggers.
• Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities.
• Assist with method remediation when biomaterials impact biological method performance.
• Support transfer of biomaterials and remediated methods to QC laboratories.
• Draft or contribute to technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA or CVB review.
• Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers.

Skills

Biomaterials

Immunoassays

Cell Separation

Biologics

Biology

cGMP Compliance

Data Analysis

Method Development

Method Validation

Microbiology

Process Monitoring

Lean Manufacturing Tools

Bioproduction

External Manufacturing

Equipment Set Up

EHS Management

Adaptability

Analytical Method Transfer

Education

Bachelor’s degree in biological science

Job description

Merck is seeking a Methods Specialist in the United States to support biomaterials management and method remediation for USDA-regulated animal health biologics. Responsibilities include maintaining documentation, inventory monitoring, and assisting with regulatory reports, while collaborating with Manufacturing, QC, QA, Regulatory Affairs, R&D, and Supply Chain.

The role requires a biology-related bachelor's degree and at least five years of experience in regulated biologics, plus expertise in