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Biomaterials Program Lead

Merck · De Soto, KS +1 more

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CMCFull-time$129k–$203kCompany career page

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Role summary

Merck seeks a Biomaterials Program Lead to oversee lifecycle management of critical biomaterials for animal health biologics production. The role encompasses knowledge management, inventory strategy, replacement sourcing, equivalence qualification, and preparation of regulatory documentation for USDA submission.

What they're looking for

  • Bachelor's degree in biological science, microbiology, genetics, virology, or related discipline
  • Minimum 7 years experience in USDA-regulated animal health biologics
  • Minimum 5 years qualifying and preparing biomaterials technical documentation for regulatory review
  • Subject matter expertise in biological method platforms such as immunoassays or cell-based methods
  • Strong technical writing skills for science-based, regulator-ready reports
  • Experience with USDA regulations and regulated quality systems
  • Cross-functional collaboration experience across Manufacturing, QC, QA, and Regulatory Affairs

What you'll be doing

  • Lead biomaterials knowledge management including documentation of production history and qualification status
  • Manage inventory strategy addressing reorder levels, lead times, expiry risks, and replacement triggers
  • Design and coordinate equivalence qualification studies for replacement biomaterials to support USDA approval
  • Lead or support method remediation when biomaterial changes impact biological test methods
  • Prepare technical reports, qualification summaries, and scientific justifications for USDA review

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