Senior Manager, Global External Manufacturing, Biologics

Description

Key Responsibilities

Senior Manager, Global External Manufacturing Biologics 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.

This position is part of the Manufacturing Operations group within the larger Pharmaceutical Development and Manufacturing organization (PDM).

Experience in leading the Manufacture of Biologics Drug Substance is a must.

This role requires 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.

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

Essential Functions

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

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

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

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 contribute to resolution of complex situations

8+ years of progressively responsible experience in a pharmaceutical / biotech organization and a BA or BS degree in science or engineering

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 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& for assistance.

The salary range for this position is : $154,020.00 - $199,320.00. 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 :

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 for assistance.