Manager, Outsourced Manufacturing

About the role

Manager, Global External Manufacturing, Small Molecule Drug Substance (DS) works to ensure 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 environmental, health, and safety legislations. This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM). This role requires collaboration with the Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy organizations within PDM to ensure successful technology transfer, commercialization, launch, routine supply, and proactive management of changes across the product lifecycle. This position will be based at the Gilead Foster City campus. Essential Functions Responsible within Global External Manufacturing to execute the network strategy. Responsible for tactical execution of the business with external manufacturing organizations, and management of supplier performance Effectively collaborates with functions within and external to PDM to achieve corporate, cross functional, and departmental goals. Responsible for coordination of inter- and intra-company technical transfers. Partners with Technical Development and internal Gilead manufacturing sites for successful technology transfer and validation of new or existing processes/products to the identified CMO(s) Executes the regular, tactical management of CMOs to ensure Gilead's products are manufactured in accordance with the registered process and approved Master Production Record Enables timely resolution of issues associated with manufacturing and/or compliance, including handling of deviations, complaints, out-of-specification investigations, Material Review Board associated investigations, finished product trending, and change control Fosters and facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability. May represent manufacturing on one or more cross-functional Development or Commercial CMC teams with responsibility for proactively managing product strategy across the life cycle from clinical supply to commercial product launch and routine supply, and then to sunset or divestiture

Requirements

• 6+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering
• An MS or MBA degree may be substituted for 2 years of relevant experience, a Ph.D. degree may be substituted for 4 years of relevant experience
• Experience in drug substance manufacturing and supply chain execution and oversight in the pharmaceutical industry
• Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Working knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
• Knowledge of the contract manufacturing organization (CMO) landscape; knowledge of CMO capabilities and limitations for worldwide drug product manufacturing is a plus
• Ability to travel internationally, including overnight up to 10% of the time is required
• Exceptional verbal and written communication skills, including ability to interact effectively with senior management at Gilead and contract manufacturing organizations.
• The salary range for this position is: $136,340.00 - $176,440.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actu

Benefits

Additional Information

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. Job Description Manager, Global External Manufacturing, Small Molecule Drug Substance

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