Senior Vice President - Global Head of ManufacturingUnited States - California - Santa MonicaManufacturing Operations & Supply ChainRegular
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. This role is based out of Kite Corporate Office, located in Santa Monica, CA.
The Global Head of Manufacturing reports to the Global Head of Technical Operations, is a member of the Technical Operations Leadership Team (TOLT) and responsible for leading Global Manufacturing at Kite. The Global Head of Manufacturing will closely collaborate with the Quality & Compliance, Process Development, Supply Chain, Facilities & Engineering, CMC Regulatory, Business Operations, IT, HR and Finance functions to ensure the success of Kite Technical Operations. You will lead the Global Manufacturing Leadership Team (GMLT), which includes the Site Operational Leaders and cross-functional partners in clinical and commercial cell therapy operations, and be responsible for developing manufacturing strategy, executing site operations, ensuring cGMP compliance, establishing new capabilities, processes and technologies, building teams and developing people, and creating an inclusive culture of safety, quality and production excellence.
Responsibilities include, but are not limited to:
- Strategy – team up with TOLT executives to establish and align on cross-functional strategies and shared global objectives. Lead the GMLT in the development of functional and site strategies, budgets, goals, objectives, etc. which are cross-functionally aligned and standardized across the network. This position will integrate and work within Kite’s Cell Therapy Operating Model and will have a significant role in aligning “one-voice” from manufacturing to Product Teams.
- Global Network – closely partner with Facilities & Engineering, IT and Finance to complete the construction, expansion and integration of 3 commercial sites, 2 clinical sites, 1 viral vector site and external sites into a fast, flexible and agile global operations network. Partner with Business Operations to ensure that global processes and systems effectively and efficiently connect and align across the sites and global functions.
- Commercial Supply - closely collaborate with Quality & Compliance, Supply Chain, Process Development, Facilities & Engineering and Finance to ensure that both internal and external site operations are executed safely, compliantly, effectively and efficiently to meet global demand and financial targets.
- Clinical Supply – in close partnership with Process Development and Clinical Quality, ensure the rapid advancement of clinical programs and development of a broad array of scientific cell therapy modalities, e.g., autologous, allogenic, bispecific, iPSC, NK cell, neoantigen, gene editing, etc.
- Compliance - closely collaborate with Quality & Compliance, and Facilities & Engineering to maintain a high level of cGMP compliance and safety through the effective monitoring and reporting of key metrics.
- Technology – closely collaborate with Process Development and IT to execute technology transfers and effectively deploy automation solutions respectively, e.g., pre-clinical programs to RDMC E/W, X19 to TCF04, Electronic Batch Record (EBR), Manufacturing Execution System (MES), Distributive Control System (DCS), etc. across the global network to advance the pipeline and improve cost, quality, success rate and cycle time.
- Continuous Improvement – closely partner with Business Operations, Finance, and Process Development to ensure process alignment and drive product/process improvements to improve reliability, quality, productivity and efficiency. Create an open, inclusive and “speak-up” environment to ensure that the best innovative solutions are identified and implemented which leads to reduction in production costs.
- Talent Development – closely collaborate with HR to build and develop an inclusive high performing leadership team, develop the next generation of leaders by creating a feedback rich culture, ensuring effective personal development of leaders, and building a strong succession pipeline.
Doctorate degree and 16+ years of operations experience
Master’s Degree and 18+ years of operations experience
Bachelor’s Degree and 20+ years of operations experience
- Education - Degree in life sciences, engineering or related field, advanced degree, e.g., MS, MBA and/or PhD with 20+ years of experience managing operational teams in the biotechnology or biologics industry with 10+ years of senior leadership experience
- International Mindset – previous regional and global responsibility, international assignment preferred. Experience leading global functions, domestic and/or international manufacturing sites.
- Interpersonal Skills – vulnerable, humble, confident, courageous. Ability to give and earn trust. High level of emotional intelligence, exceptional listening, verbal and written communication skills.
- Decision Making - proven ability to make objective, inclusive, robust and unbiased decisions with imperfect information. Ability to embrace other people’s point of view - especially if different than one’s own.
- Collaboration – cross-functional, corporate and site experience with a focus on bringing diverse perspectives together, sharing best practices, and effectively leveraging resources in an inclusive manner to further Kite’s enterprise strategy and achieve Technical Operation’s objectives.
- Change Management - effective Sponsorship, Change Agent and influencing skills. Adaptive, agile, flexible, open minded. Proven ability to build cross-functional commitment, lead, simplify and scale complex dynamic organizations through transformational change.
- Business & Scientific Acumen - broad understanding of the business model, science, facilities, engineering, process development, supply chain, quality, compliance, regulatory, and information technology expectations for cell therapy.
- Drug Development - understands product life cycle management from early clinical phases through commercialization, and how to translate innovative clinical process and assay development into regulatory strategy to gain Health Authority approval and advance the pipeline.
- Enterprise Leadership - ability to build inclusion, empowerment and accountability across teams and functions by being bold in aspiration and agile in execution, caring and making time for people, listening, speaking openly and explaining the “why”, trusting in others and oneself to make sound decisions, and then driving a consistent implementation of those decisions across a global network that requires standardization.
- Entrepreneurial - high energy level with a positive “can do” attitude, ability to adapt and think “out of the box” and rapidly turn ideas into action in a nascent, evolving, innovative industry. Manage ambiguity with aplomb and calmness. Creative, innovative and comfortable with risk-taking.