Methods Specialist

Merck · De Soto, KS +1 more

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OtherFull-time$79k–$125kCompany career page

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Role summary

Merck seeks a Methods Specialist to support biomaterials management and regulatory compliance for USDA-regulated animal health biologics. The role involves maintaining documentation, monitoring inventory, supporting qualification activities, and preparing technical reports for regulatory review.

What they're looking for

Bachelor's degree in biological science (Biology, Microbiology, Genetics, Virology, or related discipline)
Minimum 5 years of experience in USDA-regulated animal health or veterinary biologics
Subject matter expertise in at least one biological method platform (immunoassays, cell-based methods, or similar)
Strong scientific documentation and technical writing skills
Experience with biomaterials qualification or regulatory technical documentation preferred
Knowledge of cGMP compliance, method validation, method transfer, or remediation preferred

What you'll be doing

Maintain biomaterials documentation including production history, characterization, inventory, and qualification status
Monitor biomaterials inventory, usage trends, expiry risks, and coordinate reordering activities
Support biomaterials replacement planning, sourcing evaluations, and equivalence qualification activities
Draft technical reports, qualification summaries, and scientific justifications for USDA regulatory review
Collaborate with Manufacturing, QC, QA, Regulatory Affairs, R&D, Supply Chain, and external suppliers

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