Senior Manager, Global External Manufacturing, Biologics

职位描述

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 fulfill their aspirations. Join Gilead and help create possible, together.

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Senior Manager, Global External Manufacturing at Gilead you will...

• Support 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.

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

Basic Qualifications

• Ph.D. with 2+ years of progressively responsible experience in a pharmaceutical/biotech organization OR

• M.S. with 6+ years of progressively responsible experience in a pharmaceutical/biotech organization OR

• B.S. with 8+ years of progressively responsible experience in a pharmaceutical/biotech organization.

Preferred Qualifications

• 8+ years of progressively responsible experience in a pharmaceutical/biotech organization

• 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

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.