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Chief of Clinical Production

2 months ago

San Mateo, California, United States Gilead Sciences Full time
Vice President, Clinical Manufacturing

At Gilead, we are dedicated to fostering a healthier world for everyone. For over 35 years, we have confronted diseases such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that enhance lives and ensure access to these treatments globally. Our ongoing battle against the world's most significant health challenges demands collaboration, determination, and an unwavering commitment to making a difference.

Every member of Gilead's team plays a crucial role in the discovery and development of transformative scientific innovations. Our employees are our most valuable asset as we strive to achieve our ambitious goals, and we are seeking the next generation of passionate and driven individuals ready to make a tangible impact.

We believe that every employee deserves exceptional leadership. People Leaders are fundamental to the employee experience at Gilead. As a leader, whether now or in the future, you will be instrumental in evolving our culture and creating an environment where every employee feels included, developed, and empowered to realize their aspirations. Join Gilead and help us create possibilities together.

Position Overview

The Vice President of Clinical Manufacturing is a key contributor to the success of our clinical manufacturing operations. This role involves providing strategic leadership, networking, and overseeing daily operations at our clinical manufacturing site. It presents a unique opportunity for a leader to engage in the development of a new project that will quickly advance to our first biologic manufacturing facility.

Key responsibilities include:

  • Collaborating in the establishment and expansion of the manufacturing site.
  • Formulating medium and long-term strategic objectives for clinical manufacturing and guiding the management team in developing and executing operational plans. Effectively communicate and garner support for business plans and future visions to ensure strategic goals are met.
  • Partnering with various functions to advocate for and implement technological innovations.
  • Upholding the highest safety standards and operational integrity.
  • Providing leadership to direct reports and cultivating a highly skilled team through recruitment, training, and development to meet both immediate and future business needs. Anticipate shifts in industry trends and regulatory landscapes that may affect Gilead's operational requirements.
  • Assessing operational headcount needs in collaboration with senior management. Mentor and develop staff, conducting regular meetings with direct reports to establish goals and objectives.
  • Collaborating on capital projects with Technical Development, Quality Assurance, and Corporate Engineering to ensure timely and budget-compliant delivery of new manufacturing capabilities.
  • Leading the development of site manufacturing budgets in conjunction with departmental heads and guidance from global manufacturing leadership. Manage expenses in line with the approved budget and maintain detailed budgetary analysis.
  • Working closely with Technical Development to ensure efficient and compliant clinical manufacturing processes.
  • Coordinating internal site technology transfers from pilot to commercial scale production for various drug substances and products.

Qualifications:

  • Extensive experience and a degree in Chemistry, Biochemistry, Chemical Engineering, or related fields.
  • An advanced degree such as an MS, MD, PharmD, PhD, or an MBA is preferred.
  • Proven experience leading biologic or small molecule manufacturing teams.
  • Experience with regulatory submissions, including IND and BLA/NDA.
  • Strong background in working with both internal and external manufacturing organizations.
  • In-depth knowledge of ICH guidelines and GMP requirements.
  • Solid understanding of current industry trends and regulatory expectations in pharmaceutical manufacturing.
  • Exceptional leadership, communication, and interpersonal skills.
  • Proven ability to develop strategies that yield results.
  • Expertise in quality risk assessment and management methodologies.

Gilead Core Values:

Integrity: Doing What’s Right

Inclusion: Encouraging Diversity

Teamwork: Working Together

Excellence: Being Your Best

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.