Director, Global External Manufacturing, Sterile Large-Molecule DP

Foster City, CA, United States

Director, Global External Manufacturing, Sterile Large-Molecule DP page is loaded Director, Global External Manufacturing, Sterile Large-Molecule DP Apply locations United States - California - Foster City time type Full time posted on Posted 30+ Days Ago job requisition id R0039723 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

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.We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.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. Join Gilead and help create possible, together.

Job Description Director, Global External Manufacturing, Sterile Drug Product ensures 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). The preferred candidate will have experience at managing, training, and mentoring staff. Experience in leading the Manufacture of Biologics Drug Product is a must.

This role requires intimate collaboration at the Team Leadership level 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.

This position will be based at the Gilead Foster City campus.

Essential Functions

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 the 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

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

Expertise in supply risk management. Possesses 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 bulk drug substance 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

A proven capability to contribute to the success of PDM and Gilead as a leader

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 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. In order to ensure reasonable accommodation for indi

viduals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.

The salary range for this position is: $205,700.00 - $266,200.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected]  for assistance.

For more information about equal employment opportunity protections, please view the  'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job.

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About Us Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

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