Biomaterials Program Lead

Job Description

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.

Required Skills:

Preferred Skills:

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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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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