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Vice President, Clinical Manufacturing, Foster City

3 months ago

Foster City, United States Gilead Sciences Full time

Vice President, Clinical Manufacturing, Foster CityAt 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 DescriptionThe Vice President of clinical manufacturing is a vital partner for the success of clinical manufacturing. The VP provides thought partnership for our partners through strategic leadership, networking and daily operations in the Foster City clinical manufacturing site. This role provides a unique opportunity for a leader to join and partner in the development of a greenfield project that will quickly evolve to our first biologic manufacturing site located in Foster City. Critical to the success of this role will be the leader’s ability to network and partner and build manufacturing’s reputation as the partner everyone wants to work with and is a model of Gilead’s leadership commitments.The role is accountable for the most diverse manufacturing site with small molecule clinical drug substance, oral drug product and biological drug substance manufacturing. Accountabilities include cGMP manufacturing team, managing production logistics, safety, quality and compliance of clinical manufacturing.Job Responsibilities:Partner in the development and build out of the Foster City location.Develop medium and long-term strategic objectives for clinical manufacturing and lead the management team in the development and implementation of operational plans. Communicate and create buy in for the business plans and vision for the future to ensure strategic goals are achieved.Partner with other functions to champion and implement technology innovation.Maintain right to operate and highest safety standards.Provide leadership to direct reports and build a highly capable team through the attraction, training, and development of the necessary skilled professionals to meet short- and long-term business needs. Anticipate shifts in industry trends and regulatory environment that will impact Gilead’s business needs and position the function to respond accordingly.Determine operational headcount projections with senior management team. Manage, coach and develop staff. Undertake periodical and regular meetings with direct reports and contribute to establishing goals and objectives.Partner on capital projects with Technical Development, Quality Assurance and Corporate Engineering to ensure on time and on budget delivery of new manufacturing capabilities.Lead the development of the site manufacturing budgets in collaboration with departmental heads and guidance from the head of global manufacturing. Manage expenses in accordance with the approved budget. Maintain a detailed budgetary analysis and act upon budget deviations.Work closely with Technical Development to ensure rapid bench to plant execution of safe, flexible and compliant clinical manufacturing.Coordinate internal site tech transfers from pilot scale to commercial scale production for small molecule drug substances, biological drug substances and oral drug products.Requirements:Experienced understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP) and solid knowledge of worldwide regulatory requirements.Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills.Demonstrated success in developing a strategy that delivered results.Expertise and track record in managing manufacturing quality in a large, global pharma company.Expert people and project management skills.Possess in-depth knowledge of industry best practices.Strong working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH guidance.Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.Prior success in working effectively with senior scientific and operations staff.Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.Qualifications:20+ years of experience and a BS, or degree in Chemistry, Biochemistry, Chemical Engineering or related disciplines.An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.Experience leading a biologic or a small molecule manufacturing team.Experience in regulatory filings including IND and BLA/NDA and post-marketing submissions.Experience working with internal and external manufacturing organizations.In-depth understanding of ICH guidelines and GMP requirements.Solid understanding of current industry trends and regulatory expectations associated with pharmaceutical manufacturing areas, including new technologies, and approaches.Exceptional interaction, leadership and communication skills are required.Leadership qualities of the successful candidate include developing high performing teams, cross functional engagement and influence, collaboration, and strategic vision.Gilead Core ValuesIntegrity (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. #J-18808-Ljbffr