Biomaterials Program Lead
Merck•De Soto, KS
•$129,000 - $203,100•Hybrid
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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.
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.
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Senior
