Biomaterials Program Lead – USDA Biologics (Hybrid)

Merck

De Soto (KS)

Hybrid

USD 129,000 - 203,000

Full time

3 days ago

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Job summary

Merck is seeking a Biomaterials Program Lead to provide technical and program leadership for the lifecycle management of critical biomaterials used in animal health biologics production and testing. You will manage biomaterials knowledge, inventory strategy, qualification studies, and documentation to support regulatory readiness.

You will coordinate with Manufacturing, QC, QA, Regulatory Affairs, R&D and external suppliers.

Qualifications

Bachelor’s degree in a biological science (Biology, Microbiology, Genetics, Virology, or related).
7+ years in USDA-regulated animal health biologics.
5+ years qualifying biomaterials documentation for regulatory review.
Subject matter expertise in at least one biological method platform.
Strong technical writing for regulator-ready reports and justifications.

Responsibilities

Lead biomaterials knowledge management including production history and inventory status.
Manage biomaterials inventory strategy including reorder levels and lead times.
Lead replacement biomaterials planning via outsourcing and internal sourcing.
Design and document equivalence qualification studies for USDA approval.
Lead or support method remediation when biomaterial issues impact test methods.
Coordinate transfer of biomaterials to QC laboratories with documentation.
Prepare technical reports and regulatory support documents for USDA review.
Partner cross-functionally with Manufacturing, QC, QA, Regulatory Affairs, R&D and external suppliers.