Gilead Sciences, Inc.
Associate Director — Material Science
Gilead Sciences, Inc., Foster City, California, United States, 94420
Associate Director — Material Science
United States - California - Foster City Process/Product Development & Operations
Regular Job Description
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. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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. 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 consistency, 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. Qualifications: 5+ 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 degree 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. Shows technical proficiency, scientific creativity, collaboration, and independent thought in proposing experimental designs and research strategies. The ability to think critically and creatively is essential and be able to work independently to determine appropriate resources for resolution of problems. Excellent verbal and written communication skills are crucial for effectively conveying complex scientific concepts, influencing stakeholders, and collaborating with cross-functional teams. Strong organizational and planning skills, with the capability to coordinate multiple projects or tasks simultaneously, ensuring deadlines are met and resources are effectively utilized. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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United States - California - Foster City Process/Product Development & Operations
Regular Job Description
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. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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. 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 consistency, 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. Qualifications: 5+ 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 degree 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. Shows technical proficiency, scientific creativity, collaboration, and independent thought in proposing experimental designs and research strategies. The ability to think critically and creatively is essential and be able to work independently to determine appropriate resources for resolution of problems. Excellent verbal and written communication skills are crucial for effectively conveying complex scientific concepts, influencing stakeholders, and collaborating with cross-functional teams. Strong organizational and planning skills, with the capability to coordinate multiple projects or tasks simultaneously, ensuring deadlines are met and resources are effectively utilized. Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. The salary range for this position is: $191,335.00 - $247,610.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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