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Process Development Sr Scientist

Amgen · Thousand Oaks, CA

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Role summary

This senior scientist role focuses on designing and executing bench-scale experiments for drug substance manufacturing, including cell culture and purification operations. The position requires applying established methods to solve process challenges, contributing to technology development, and collaborating across functional teams to deliver cGMP-compliant manufacturing processes and regulatory documentation.

What they're looking for

  • PhD, PharmD, or MD; or Master's degree with 3+ years scientific experience; or Bachelor's degree with 5+ years scientific experience
  • Hands-on experience with cell culture or purification operations
  • Advanced understanding of bioreactor production, chromatography, tangential flow filtration, filtration techniques
  • Experience developing and supporting biomanufacturing processes including scale-up and GMP production
  • Proficiency with data analytical tools such as Excel, Spotfire, JMP, R, or Python
  • Excellent written and oral communication skills with strong interpersonal abilities
  • Familiarity with design of experiments and statistical analysis of data

What you'll be doing

  • Design and execute bench-scale experiments across drug substance process spanning cell culture and purification
  • Apply platform approaches and problem-solving skills to rapidly address drug substance challenges
  • Contribute to technology development and innovation initiatives within process development
  • Collaborate cross-functionally with analytical and drug product teams to deliver manufacturing processes
  • Author or direct authorship of technical reports and CMC regulatory submissions for drug development

Privacy & handoff

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RoleLantern checkedNeeds clarity
Date posted30 days ago
Last source check1 day ago
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