Gilead Sciences, Inc.Foster City, CA, United States
2 days ago
Job type
Full-time
Job description
Performs as a leader within Global External Manufacturing to execute the network strategy. Responsible for tactical manufacturing strategy, execution of the business with external manufacturing organizations, and management of supplier performance
Partner in development of department strategy aligned with corporate and PDM goals into functional / departmental objectives to realize the targeted outcomes
Proactively and effectively leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals
In collaboration with Technical Development Organization, defines the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the network CMOs to achieve Gilead’s strategic and tactical business outcomes, including Key Performance Indicators
Proactively 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)
Leads 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 complex 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 Gilead as a liaison between the company and various governmental agencies as required
Demonstrated track record in oral solid dosage drug product manufacturing and supply chain execution in the pharmaceutical industry
Expertise in supply risk management, possessing in-depth knowledge of industry and system best practices
Experience and / or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP). Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance
Solid understanding 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
Demonstrated ability to understand and resolve complex situations
Proven leadership capability to contribute to the success of PDM and Gilead
12+ years of progressively responsible experience in a pharmaceutical / biotech organization and a BA or BS degree in science or engineering, an advanced degree in science, engineering, or business is desirable
An MBA degree can be substituted for 2 years of relevant experience, a Ph.D. degree can be substituted for 4 years of relevant experience
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Director Manufacturing • Foster City, CA, United States
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