Director, Global External Manufacturing, OSD
Scorpion Therapeutics, San Francisco, California, United States, 94199
Role Summary
Director, Global External Manufacturing Oral-Solid Dosage (OSD) leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through external contract manufacturing networks, while ensuring compliance with cGMP, regulatory requirements, and EH&S regulations. This role is part of the Manufacturing Operations group within the Pharmaceutical Development and Manufacturing organization, with a focus on managing external CMOs, technology transfer, and lifecycle management across product launch to sunset/divestiture. Collaboration across Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy is essential to achieve successful technology transfer, commercialization, launch, routine supply, and proactive change management. Responsibilities
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 Qualifications
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 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience Education
BA or BS in science or engineering; advanced degree (MS, MBA, PhD) preferred Additional Requirements
Travel up to 10% internationally
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Director, Global External Manufacturing Oral-Solid Dosage (OSD) leads a team to ensure uninterrupted supply of Gilead’s clinical and commercial products through external contract manufacturing networks, while ensuring compliance with cGMP, regulatory requirements, and EH&S regulations. This role is part of the Manufacturing Operations group within the Pharmaceutical Development and Manufacturing organization, with a focus on managing external CMOs, technology transfer, and lifecycle management across product launch to sunset/divestiture. Collaboration across Development, Quality, Regulatory, Analytical, Supply Chain, and Product & Portfolio Strategy is essential to achieve successful technology transfer, commercialization, launch, routine supply, and proactive change management. Responsibilities
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 Qualifications
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 10 years of relevant experience, a Ph.D. degree can be substituted for 8 years of relevant experience Education
BA or BS in science or engineering; advanced degree (MS, MBA, PhD) preferred Additional Requirements
Travel up to 10% internationally
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