Senior Director, IT Manufacturing and Process DevelopmentUnited States - California - Santa MonicaInformation TechnologyRegular
Kite Pharma, a Gilead Company, is seeking a highly motivated and experienced IT Senior Director within the Technical Operations group of IT.
The Senior Director, IT Manufacturing and Process Development will liaise with Kite’s manufacturing and process development system leads and be responsible for delivering technology solutions that will enable Kite’s manufacturing needs and facilitate the standardization of IT systems across facilities globally. This role provides business process development, solution development and project oversight and accountability. This role will also lead global Kite Manufacturing applications such as Mfg. Scheduling, MES, ROBAR Printing, Data Warehousing and Integrations between the systems. This will be a critical role within the Kite IT reporting to the Executive Director of Technical Operations IT. It is a highly cross functional role working closely with the leadership team from various business groups, Gilead and Kite IT.
KEY RESPONSIBILITIES include but are not limited to:
- Provide the long-term strategy and implementation plan of key technology solutions to support Manufacturing and Process Development capabilities.
- Articulate and present a technology Road Map (1-3-5 year) for our Global Manufacturing and Process Development business units. This include to re-design our Tech Ops system architecture entirely. This comprehends the development, design, and then refining for expansion and change to best support the business and the patient.
- Participate in the Global Manufacturing business leadership team to understand their technology requirements and identify/implement “best fit” technology solutions to meet their needs.
- Provide stewardship and effective management of IT resources and investments, including oversight of resource requirements, Mfg and PD project portfolios, departmental budgets and staffing plans, and management of IT vendors and service providers.
- Enforce IT Governance and Change control amongst IT, quality and business teams to prioritize and implement improvements for all Manufacturing systems.
- Partner with other IT leads (infrastructure, service desk, IT security, and portfolio management) on the overall IT solutions delivery process and infrastructure and database requirements.
- Evaluate vendor solutions, develop alternatives and recommend technical solutions that align with Kite’s Global IT standards and meet the growth of the manufacturing facilities.
- Operational ownership of various Manufacturing systems in an FDA regulated biotech or pharmaceutical environment.
- Lead and manage manufacturing system implementations from requirement management through development/configuration and deployment.
- Collaborate with Site IT leads to standardize and consolidate technology solutions to reduce IT footprint, maintain data integrity and minimize security risk.
- Collaborate with Site IT leads to plan, coordinate, direct, and lead the design, implementation and support of IT-related activities of their site.
- Bring best practices to deliver solutions for the business problems through experience driven vision, planning and hands on experience within a regulated GxP environment.
- Build and maintain an organization of talent – in a matrix operating model -- that meet the needs of the business. Develop, motivate, lead and manage this team, including identifying leaders and developing managers.
- Participate in discussion with Industry experts and research institutions to understand the future manufacturing
- BS in Life Sciences, Engineering, Computer Science and 14+ years’ experience in GxP regulated setting -OR-
- MS in Life Sciences, Engineering, Computer Science and 12+ years’ experience in GxP regulated setting -OR-
- PhD in Life Sciences, Engineering, Computer Science and 12+ years’ experience in GxP regulated setting
- MS preferred
- Minimum of 15 years of working within a GxP regulated setting (Laboratory, Quality, Process Development, Manufacturing, IT).
- Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11. GAMP knowledge
- 10+ years of experience in implementing systems for manufacturing and integrating them with other enterprise and technical operations systems.
- Experience with various manufacturing level 1-2 instruments used with engineering and manufacturing and integrating them with other systems.
- Experience with Manufacturing Execution system, Electronic Batch Records systems like Werum, and label printing solutions like Robar.
- Experience with EMS/BMS, CMMS, and other facilities & engineering systems will be a plus.
- Experience in building a data warehouse for biotech or pharmaceutical organization, with data from various quality, product development and manufacturing systems.
- Experience with data analytics and reporting for site and functional needs.
- Experience in handling infrastructure and instruments qualifications and validations for regulatory requirements.
- Experience with emerging cloud, SaaS and web technologies.
- Ability to handle conflicting priorities from various business groups and prioritize them based on the business requirements and resource availability.
- Experience in implementing and leading change management and governance process, owning deviations and change control in a regulated environment.
- Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines in a fast paced environment.
- Strong written and verbal communication and presentation skills with good executive presence to interact with senior leadership team from various business groups. Proficient in tools like Power Point, Visio and other tools to develop process flows and presentations.
- Experience in leading, managing and mentoring a team of technical operations or manufacturing IT professionals.