Senior Biologics Engineer II

5 days ago


San Mateo, California, United States Gilead Sciences Full time
About the Role

Gilead Sciences, Inc. is a research-based biopharmaceutical company that has made significant contributions to the development of life-saving therapies. We are seeking a highly skilled Senior Biologics Engineer II to join our team and contribute to the commercial manufacture of drug substance.

Key Responsibilities
  • Represent Manufacturing, Science and Technology (MSAT) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities to support commercial manufacture of drug substance.
  • Lead or contribute to project workstreams such as risk assessments, control strategy management, continuous improvement, and change management throughout the product lifecycle.
  • Collaborate with Process Development group to support continuous improvement initiatives.
  • Review and approve technical documentation including protocols, master batch records, deviation records, and reports for commercial campaigns.
  • Author manufacture sections of regulatory filings in support of commercial product lifecycle management.
  • Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
Requirements
  • Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience.
  • Strong understanding of biologics drug substance manufacturing processes with focus on downstream purification operations.
  • Experience supporting drug substance manufacturing operations, technology transfer, and/or development.
  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
  • Excellent troubleshooting skills and ability to solve complex technical issues.
About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Our company operates in more than 35 countries worldwide, with headquarters in Foster City, California.



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