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Associate Director of Materials Science
2 months ago
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We are seeking an Associate Director of Material Science to lead our biologics development efforts and ensure the continuity of supply and mitigation of materials risks for our manufacturing sites.
Key Responsibilities:- Lead cross-functional teams involving Pharmaceutical Development & Manufacturing, Quality, Supply Chain, Manufacturing, Regulatory Affairs CMC, Finance, and Technical Development throughout all stages of biologics development.
- Develop strategies to align with health authority expectations, including conducting supplier technical due diligences and formulating science and risk-based material specifications.
- 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.
- 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.
- A competitive salary range of $177,000 to $230,000.
- A discretionary annual bonus and discretionary stock-based long-term incentives.
- A comprehensive benefits package, including company-sponsored medical, dental, vision, and life insurance plans.
Gilead Sciences, Inc. is an equal opportunity employer committed to a diverse workforce. We welcome applications from qualified candidates who share our values of integrity, inclusion, teamwork, excellence, and accountability.
