Senior Manager, Global External Manufacturing, Sterile Drug Product
Gilead Sciences, Inc.
2024-11-05 18:42:18
San Mateo,
California,
United States
Job type: fulltime
Job industry: Manufacturing Operations
Job description
Senior Manager, Global External Manufacturing, Sterile Drug Product
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the company's five core values. That's because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly
For Current Gilead Employees and Contractors:
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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.
Job Description
Senior Manager, Global External Manufacturing, Sterile Drug Product manages 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 Sterile Drug Product is a must.
This role requires collaboration 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:
- Leads 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
- Supports 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
- Part of the team to define the technical requirements and actively partners with Global Supply Chain in selection of CMOs, and influences overall performance of the CMO network 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 small or large-molecule drug product manufacturing and supply chain execution and oversight in the pharmaceutical industry
- Experience in supply risk management. Possesses strong 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 drug product manufacturing is a plus
- Ability to travel domestic and international up to 20% 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
Education:
- 8+ years of progressively responsible experience including development, manufacturing, or outsourcing in a pharmaceutical/biotech organization and a BA or BS degree in science or engineering minimally required OR
- An MBA/MS degree can be substituted for 2 years of relevant experience OR
- Ph.D. degree with 0+ years required (preference for 1-2 years of post-doc experience)
Gilead Core Values:
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 .
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Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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