Senior Manager, Global External Manufacturing, Biologics

Gilead Sciences • Foster City, CA

97d • $157,590 - $203,940

About The Position

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.

Requirements

• 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.
• Possesses knowledge of industry and system best practices.
• Working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
• Solid knowledge of worldwide regulatory requirements, including pharmaceutical ICH guidance.
• Understanding of the contract manufacturing organization (CMO) landscape.
• Ability to travel internationally, including overnight up to 10% of the time.
• Exceptional verbal and written communication skills.
• Demonstrated ability to understand and contribute to resolution of complex situations.
• 8+ years of progressively responsible experience in a pharmaceutical/biotech organization.
• BA or BS degree in science or engineering.

Nice To Haves

• 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.
• Knowledge of CMO capabilities and limitations for worldwide bulk drug substance manufacturing.

Responsibilities

• Support uninterrupted supply of Gilead’s clinical and commercial products through execution of manufacturing campaigns within our global external contract manufacturing network.
• Ensure compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations.
• Execute the network strategy within Global External Manufacturing.
• Lead collaboration with functions within and external to PDM to achieve corporate, cross functional, and departmental goals.
• Define technical requirements in collaboration with Technical Development Organization and partner with Global Supply Chain in selection of CMOs.
• Coordinate inter- and intra-company technical transfers.
• Manage CMOs to ensure Gilead’s products are manufactured in accordance with the registered process and approved Master Production Record.
• Resolve complex issues associated with manufacturing and/or compliance.
• Foster and facilitate continuous improvement of production and business processes.
• Represent manufacturing on cross-functional Development or Commercial CMC teams.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees