Biomaterials Methods Specialist: Regulatory & QC Support

CamWebDir; Rahway (NJ); Hybrid; GBP 60,000 - 94,000; Full time

Job summary

Merck & Co., Inc. is seeking a Methods Specialist to support biomaterials management, documentation, and regulatory activities for USDA-regulated biologics.

The role ensures accurate inventory, qualification, and method remediation while coordinating with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external partners. The candidate will develop expertise in at least one biological method platform, produce technical reports, and assist with regulatory submissions.

Qualifications

• Bachelor’s degree in a biological science such as Biology, Microbiology, Genetics, Virology, or closely related discipline.
• 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 (e.g., immunoassays, cell-based methods, or related test systems).

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

Adaptability

Analytical Method Transfer

Biomaterials

Biology

Bioproducts

Immunoassays

Cell Separation

cGMP Compliance

Column Chromatography

Data Analysis

Computer Literacy

Education

Bachelor’s degree in Biological science

Tools

Column Chromatography

Computer Literacy

Job description

Merck & Co., Inc. is seeking a Methods Specialist to support biomaterials management, documentation, and regulatory activities for USDA-regulated biologics.

The role ensures accurate inventory, qualification, and method remediation while coordinating with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external partners. The candidate will develop expertise in at least one biological method platform, produce technical reports, and assist with regulatory submissions.