Gilead Sciences
Senior Manager, Global External Manufacturing, Biologics
Gilead Sciences, San Francisco, California, United States, 94199
Senior Manager, Global External Manufacturing, Biologics
Join to apply for the Senior Manager, Global External Manufacturing, Biologics role at Gilead Sciences. 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. Job Description Key Responsibilities Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and EH&S legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. Collaborates at the Team Leadership level with Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle. Based at the Gilead Foster City campus. Executes the regular, tactical management of CMOs to ensure products are manufactured in accordance with the registered process and approved Master Production Record. Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-spec investigations, Material Review Board investigations, finished product trending, and change control. Fosters continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent manufacturing on cross-functional Development or Commercial CMC teams with responsibility for proactive product strategy across the life cycle from clinical supply to commercial product launch and routine supply. Basic Qualifications Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization OR M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization OR B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization. Preferred Qualifications 8+ years of progressively responsible experience in a pharmaceutical/biotech organization Experience in sterile large-molecule drug substance or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry Experience in supply risk management. Possesses knowledge of industry and system best practices Experience and/or working understanding of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance Understanding of the contract manufacturing organization (CMO) landscape. Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing is a plus Ability to travel internationally, including overnight up to 10% of the time Exceptional verbal and written communication skills, including ability to interact effectively with senior management Demonstrated ability to understand and contribute to resolution of complex situations Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinions.
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Join to apply for the Senior Manager, Global External Manufacturing, Biologics role at Gilead Sciences. 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. Job Description Key Responsibilities Senior Manager, Global External Manufacturing Biologics supports uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and EH&S legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). Experience in leading the Manufacture of Biologics Drug Substance is a must. Collaborates at the Team Leadership level with Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle. Based at the Gilead Foster City campus. Executes the regular, tactical management of CMOs to ensure products are manufactured in accordance with the registered process and approved Master Production Record. Enables timely resolution of complex issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-spec investigations, Material Review Board investigations, finished product trending, and change control. Fosters continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent manufacturing on cross-functional Development or Commercial CMC teams with responsibility for proactive product strategy across the life cycle from clinical supply to commercial product launch and routine supply. Basic Qualifications Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization OR M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization OR B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization. Preferred Qualifications 8+ years of progressively responsible experience in a pharmaceutical/biotech organization Experience in sterile large-molecule drug substance or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry Experience in supply risk management. Possesses knowledge of industry and system best practices Experience and/or working understanding of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance Understanding of the contract manufacturing organization (CMO) landscape. Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing is a plus Ability to travel internationally, including overnight up to 10% of the time Exceptional verbal and written communication skills, including ability to interact effectively with senior management Demonstrated ability to understand and contribute to resolution of complex situations Gilead Core Values Integrity (Doing What’s Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinions.
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