Senior Manager, Global External Manufacturing, Biologics

Senior Manager, Global External Manufacturing, Biologics

United States - California - Foster City Manufacturing Operations & Supply Chain Regular

Read on to fully understand what this job requires in terms of skills and experience If you are a good match, make an application.

Job Description

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.

Key Responsibilities

• Supports 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.
• Collaborates at the Team Leadership level with 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.
• Executes the network strategy and manages supplier performance in collaboration with external manufacturing organizations.
• Leads collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals.
• Defines technical requirements and partners with Global Supply Chain in selection of CMOs, influencing overall performance to achieve Gilead’s strategic and tactical business outcomes.
• Coordinates inter- and intra-company technical transfers with Technical Development Organization.
• Manages CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record.
• Resolves complex issues associated with manufacturing and / or compliance, including deviations, complaints, and change control.
• Facilitates continuous improvement of production and business processes to reduce cost, improve quality, increase efficiency, and ensure sustainability.
• Represents manufacturing on cross-functional Development or Commercial CMC teams with responsibility for managing product strategy across the life cycle from clinical supply to commercial product launch and routine supply.

Qualifications

• 8+ years of progressively responsible experience in a pharmaceutical / biotech organization and a BA or BS degree in science or engineering.
• Experienced in sterile large-molecule drug substance or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry.
• Experience in supply risk management and knowledge of industry best practices.
• Understanding of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and worldwide regulatory requirements, including pharmaceutical ICH guidance.
• Knowledge of the contract manufacturing organization (CMO) landscape and capabilities for worldwide bulk drug substance manufacturing.
• Ability to travel internationally, including overnight up to 10% of the time.
• Exceptional verbal and written communication skills, including ability to interact effectively with senior management.
• Demonstrated ability to resolve complex situations.
• An MBA degree can be substituted for 2 years of relevant experience, a Ph.D. degree may be substituted for 4 years of relevant experience.

Gilead Core Values

• Integrity (Doing What’s Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. To ensure reasonable accommodation for individuals protected by applicable laws, applicants who require accommodation in the job application process may contact [email protected] for assistance.

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