Associate Director — Material Science (Pivotal & Commercial Biologics)

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

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Job Description
 

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Associate Director — Material Science (Pivotal & Commercial Biologics)

Role Summary:

• Leads and contributes to cross-functional teams involving various departments such as Pharmaceutical Development & Manufacturing (PDM), Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance, and Technical Development throughout all stages of biologics development.
• Leads projects within the Materials Strategy Team to ensure continuity of supply and mitigate materials risks for Gilead's manufacturing sites.
• Provides technical support for the selection, design, characterization, and performance evaluation of raw materials and single use components used in manufacturing and analytical testing across all biologics programs.
• Leads projects within the Materials Strategy Team to ensure continuity of supply and mitigate materials risks for Gilead's manufacturing sites.
• Develops strategies to align with health authority expectations, including conducting supplier technical due diligences and formulating science and risk-based material specifications.
• Leads efforts to establish standards for raw materials and single-use components in collaboration with Quality and Supply Chain teams, to ensure consisitency, compliance and efficiency in manufacturing processes.
• Plays a crucial role in post-launch Life Cycle Management (LCM) activities, ensuring continuous improvement and compliance with regulatory standards.
• Conducts hands-on laboratory experiments as needed to troubleshoot issues or select appropriate materials for biologics manufacturing.
• Acts as a subject matter expert in regulatory filings, process validation, and regulatory inspections, contributing to the successful approval and compliance of biologics programs.
• Promotes scientific innovation and technology adoption to enhance material assessment for process development and manufacturing efficiency.
• Scientific and technical mentorship to individuals and project teams across multiple programs, fostering development and knowledge sharing within the organization.
• Recognized as a scientific resource both within the department and potentially outside Gilead, contributing to publications and reviewing drafts to share insights and advancements in the field.