Senior Manager, Global External Manufacturing, Sterile Drug Product

Senior Manager, Global External Manufacturing, Sterile Drug Product

Ireland - Cork Manufacturing Operations & Supply Chain Regular

Senior Manager, Global External Manufacturing, Sterile Drug Product manages 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). Experience in leading the Manufacture of Sterile Drug Product is a must.

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 from launch to sunset/divestiture.

We are open to a site-based candidate at either Foster City, CA or Cork, Ireland.

Essential Functions

- Leads 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

- Supports 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

- Part of the team to define the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the CMO network 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)

- 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 sterile small or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry

- Experience in supply risk management. Possesses strong 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 domestic and international up to 20% of the time is required

- 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

Education

- consolidated years of progressively responsible experience including development, manufacturing, or outsourcing in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering minimally required OR

- An MBA/MS degree can be substituted for relevant experience OR

- Ph.D. degree with no experience required (preference for 1-2 years of post-doc experience)

Gilead Core Values

- Integrity (Doing What’s Right)

- Teamwork (Working Together)

- Excellence (Being Your Best)

- Accountability (Taking Personal Responsibility)

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