Biomaterials Method Specialist for Regulatory QC

HireLifeScience; Elkhorn Precinct (NE); Hybrid; USD 79,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays

Vacation and sick days

Job summary

HireLifeScience is seeking a Methods Specialist to support biomaterials management and regulatory documentation for USDA-regulated animal health biologics. The role involves inventory oversight, method remediation support, and collaboration with QC, Regulatory, and R&D teams.

Qualifications include a biology degree, 5+ years in USDA-regulated biologics, and strong technical writing skills. Hybrid work arrangement with a comprehensive benefits package is offered.

Qualifications

• Bachelor's degree in Biological sciences or closely related discipline.
• Minimum of 5 years of experience in USDA-regulated animal health biologics or veterinary biologics.
• Developing subject matter expertise in at least one biological method platform (immunoassays, cell-based methods, etc.).
• Strong scientific documentation and technical writing skills.

Responsibilities

• Maintain biomaterials documentation including production history, 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, science justifications, and regulatory support documents.

Skills

Adaptability

Analytical method transfer

Biomaterials

Biologics

Bioproducts

Quality systems

Documentation

Education

Bachelor's degree in Biological sciences

Job description

HireLifeScience is seeking a Methods Specialist to support biomaterials management and regulatory documentation for USDA-regulated animal health biologics. The role involves inventory oversight, method remediation support, and collaboration with QC, Regulatory, and R&D teams.

Qualifications include a biology degree, 5+ years in USDA-regulated biologics, and strong technical writing skills. Hybrid work arrangement with a comprehensive benefits package is offered.