Associate Director Material Science

5 days ago

Foster City, California, United States Gilead Sciences Full time
Role Summary:

As an Associate Director of Material Science, you will lead cross-functional teams to ensure continuity of supply and mitigate materials risks for Gilead's manufacturing sites. You will provide 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.

Key Responsibilities:
  • Lead projects within the Materials Strategy Team to ensure continuity of supply and mitigate materials risks for Gilead's manufacturing sites.
  • Provide 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.
  • Develop strategies to align with health authority expectations, including conducting supplier technical due diligences and formulating science and risk-based material specifications.
  • Lead efforts to establish standards for raw materials and single-use components in collaboration with Quality and Supply Chain teams, to ensure consistency, compliance, and efficiency in manufacturing processes.
  • Conduct hands-on laboratory experiments as needed to troubleshoot issues or select appropriate materials for biologics manufacturing.
  • Act as a subject matter expert in regulatory filings, process validation, and regulatory inspections, contributing to the successful approval and compliance of biologics programs.
  • Promote 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.
Requirements:
  • 2+ years of relevant experience with a PhD in a relevant scientific discipline, OR 8+ years of industry experience with a MS degree, OR 10+ years of industry experience with a BS.
  • Strong background in biologics development and manufacturing, with expertise in raw materials selection, characterization, and process optimization.
  • Proficiency in single-use systems, resins, filter technologies, injection molding, and plastic films. Understanding of extractables, leachables, and Pharmacopeia compliance.
  • Well-acquainted with industry best practices, guidelines, and emerging trends. Knowledgeable about regulatory requirements and processes related to biologics development, ensuring compliance and successful regulatory submissions.
  • Ability to lead and collaborate effectively in cross-functional teams, ensuring alignment and progress across diverse departments.
  • Outstanding communication, decision-making, and interpersonal skills.
  • Demonstrated ability to influence and shape industry standards, with a notable presence in the scientific community.
About Gilead Sciences:

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.

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