Executive Director, Sterile Process Engineering and Packaging

4 days left

Gilead Sciences, Inc.
San Mateo, California
Feb 04, 2024
Feb 26, 2024
Position Type
Engineer, Executive
Full Time
Organization Type
Executive Director, Sterile Process Engineering and Packaging
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

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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.
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

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The Executive Director, Sterile Process Engineering and Packaging, will fulfill a strategic leadership role within the DDCPE organization that develops clinical and commercial devices, packaging, and fill/finish and assembly processes for combination products in the Gilead portfolio. The incumbent will be responsible for developing global, end-to-end capabilities for the design, development, scale-up, and validation of processes for late-stage sterile drug product unit operations, including assembly and packaging, for both small and large molecule parenteral drugs in the portfolio. The Executive Director SPEP will both excel in and foster an environment of cross-functional collaboration, accountability, influence, and technical rigor, working with teams such as Formulation, Clinical Packaging, Device Engineering, Manufacturing Operations, Supply Chain, and others, to ensure rapid development and commercialization of robust, compliant processes and effective lifecycle management. The successful candidate will be creative, open-minded, highly motivated, results-oriented, have high learning agility, and will be an experienced people leader who develops, inspires, and empowers strong teams.

Specific Job Responsibilities
  • Serve as a member of the DDCPE Leadership Team responsible for developing and establishing strategy and site operations. Provide plans, roadmaps, updates and KPIs to leadership.
  • Provide technical and strategic leadership to sterile drug processes for late-stage programs to enable the manufacture of high-quality, cost-effective, compliant, and lifesaving parenterals to patients. Represent the SPEP function and expertise both internally and externally.
  • Lead current team ( 4 FTE's) and build out group to design, develop, scale-up, and validate processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals. Scope includes development and technical support of clinical and commercial processes, technology transfer to internal and outsourced manufacturing, and ad-hoc technical support for commercial production as needed.
  • Closely collaborate with Clinical Packaging, Device Engineering, and Manufacturing Operations to ensure smooth transitions and appropriately staged investments from early development to commercialization.
  • Drive the establishment and maintenance of a state-of-the-art sterile process engineering lab
  • Keep abreast of technology, market and regulatory trends in sterile processing, assembly, and packaging of combination products and identify portfolio gaps and opportunities for strategic innovation that drive and support pipeline development / technology development roadmap and life cycle management (LCM) decisions, in alignment with organizational and corporate goals.
  • Influence regulatory strategies; drive and provide oversight and reviews of the relevant sections related to sterile process unit operations and packaging for regulatory filings (IND, NDA, BLA) to support global regulatory submissions.
  • Drive and where appropriate lead the selection and qualification and maintenance of a platform parenteral container closure system for both vials and pre-filled syringes.
  • Lead business process, operations, and technology initiatives to improve project execution and efficiency; drive a culture of innovation, high-quality, and science-based engineering.
  • Champion sustainability initiatives within to meet Gilead's ambition (reduce absolute scope 1 and 2 greenhouse gas (GHG) emissions 46% and absolute scope 3 GHG emissions 15% by 2030).
  • Remove roadblocks related to complex technical or business challenges faced by the SPEP team
  • Lead, develop, and coach staff, creating strategies to evolve the capabilities of the organization in alignment with Gilead's growth strategies.
  • Lead by example in demonstrating Gilead's Core Values of Integrity, Inclusion, Teamwork, Excellence, and Accountability.

  • Advanced degree in science, pharmaceutics, engineering, or related field, with relevant industry experience: BA/BS degree and a minimum of sixteen (16) years of experience, OR a Ph.D. degree and a minimum of fourteen (14) years of relevant industry experience.
  • At least ten (10) years of significant leadership/management experience. Demonstrated ability to effectively develop and lead high performing global organizations of industry leading and exceptionally talented experts.
  • Thorough knowledge of FDA and cGMP standards, parenteral packaging and devices, combination products, and drug product manufacturing and sterile processing.
  • Strong technical and scientific acumen with proven ability to develop and implement strategies to optimize and de-risk processes.
  • Demonstrated ability to develop and execute organizational and business strategy to bring maximum value to the organization.
  • Excellent verbal, written, and interpersonal communication skills are required.
  • Demonstrated ability to lead through influence in a matrixed corporate environment and at a senior level within the organization.

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About Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical 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 . click apply for full job details