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Scientific Director

Amgen · Thousand Oaks, CA

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Role summary

This Scientific Director role leads the Product Stewardship Toxicology function within Amgen's EHSS organization. The position provides strategic scientific leadership in pharmaceutical and occupational toxicology, overseeing toxicological assessments for drug development, manufacturing, and commercialization while ensuring regulatory compliance and patient safety. The hybrid role requires deep expertise in toxicology risk assessment and cross-functional collaboration across development, quality, and regulatory teams.

What they're looking for

  • Doctorate (PhD, PharmD, or MD) with 5 years related experience, or Master's with 8 years, or Bachelor's with 10 years
  • Expertise in pharmaceutical toxicology, occupational toxicology, and product quality toxicology
  • Knowledge of extractables and leachable risk assessment and ISO 10993 biological evaluations
  • DABT, ERT, or equivalent professional toxicology certification strongly preferred
  • Significant pharmaceutical or biotechnology industry experience
  • Leadership capability in cross-functional scientific teams and strategic decision-making

What you'll be doing

  • Lead Product Stewardship Toxicology function and develop global toxicology strategies for product lifecycle
  • Conduct toxicological risk assessments for extractables, leachables, packaging, devices, and combination products
  • Establish occupational toxicology programs including OEB classifications and OEL derivations
  • Mentor scientific staff and drive continuous improvement across toxicology processes and governance
  • Represent Amgen in external scientific organizations and influence industry regulatory standards

Privacy & handoff

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted43 days ago
Last source check1 day ago
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