Senior Manager, Global External Manufacturing, Biologics

Role Summary

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Global External Manufacturing at Gilead you will...

Responsibilities

• Responsible 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
• 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, part of the team that 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
• In collaboration with Technical Development Organization, coordination of inter- and intra-company technical transfers. 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)
• 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 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 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

Qualifications

• Required: Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization
• Required: M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization
• Required: B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization
• Preferred: 8+ years of progressively responsible experience in a pharmaceutical/biotech organization
• Preferred: Experienced in sterile large-molecule drug substance or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
• Preferred: Experience in supply risk management. Possesses knowledge of industry and system best practices
• Preferred: 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
• Preferred: Understanding of the contract manufacturing organization (CMO) landscape. Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing is a plus
• Preferred: Ability to travel internationally, including overnight up to 10% of the time
• Preferred: Exceptional verbal and written communication skills, including ability to interact effectively with senior management
• Preferred: Demonstrated ability to understand and contribute to resolution of complex situations