Biomaterials Program Lead

The Biomaterials Program Lead will provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing. This role is responsible for biomaterials knowledge management, inventory and reorder strategy, replacement sourcing, equivalence qualification, method remediation, QC transfer support, and preparation of USDA-ready technical reports.

Key Responsibilities

• Lead biomaterials knowledge management, including documentation of production history, characterization, inventory status, qualification status, and method dependencies.
• Manage biomaterials inventory strategy, including reorder levels, usage trends, lead times, expiry risks, and replacement triggers.
• Lead replacement biomaterials planning through outsourcing, commercial vendors, and internal sourcing options.
• Design, coordinate, and document equivalence qualification studies for replacement biomaterials to support USDA approval.
• Lead or support method remediation when biomaterial changes or performance issues impact biological test methods.
• Coordinate transfer of biomaterials and remediated methods to QC laboratories, ensuring documentation and readiness expectations are met.
• Prepare technical reports, qualification summaries, scientific justifications, and regulatory support documents for USDA review.
• Partner cross-functionally with Manufacturing, QC, QA, Regulatory Affairs, R&D, and external suppliers.

Minimum Qualifications

• Bachelor’s degree in a biological science, such as Biology, Microbiology, Genetics, Virology, or a 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, cell-based methods, or other relevant biological test systems.
• Strong technical writing skills with the ability to prepare clear, science-based, regulator-ready reports and justifications.

Preferred Qualifications

• Experience working with USDA.
• Experience with regulated quality systems.
• Experience with method validation and transfer.
• Experience collaborating across Manufacturing, QC, QA, Regulatory Affairs, R&D, and external organizations.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.