Associate Director, Site IT LeadUnited States - Maryland - FrederickInformation TechnologyRegular
Kite Pharma, a Gilead Company, is seeking a highly motivated and experienced IT Associate Director within the Technical Operations group of IT.
The Associate Director, Site IT Lead responsible for one of our Kite and Gilead Manufacturing Sites in the US to support our Cell Therapy strategies and manufacturing business capabilities. This leadership role will partner with our local and global manufacturing teams and respective Tech Ops partners. Position is based at Frederick, Maryland Manufacturing site. This will be a critical role within the Kite IT reporting to the Senior 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:
Strategy and Roadmap:
- Lead the Site Technology Council for site technology roadmap and project implementation.
- Partners with Site Operational Technology Lead on the IT strategy, local IT architecture design systems and IT solutions following overall Global System Architecture, and respective business systems roadmap for the site.
- Partners with Local Site Process/Systems owners, with input from Global COE’s and Kite IT to prioritize local portfolio and align to above roadmap.
- IT Site single point of contact for business systems issues, support and upgrades.
- Single point of contact with Global IT Programs and Global IT and Applications support for site.
- Accountable for local IT budget that rolls up to Cell Therapy IT
- Understand business processes and regulatory environment
- Accountable and responsible to assess impact of IT Enterprise (either Gilead of Kite Global) projects that requires to be implemented at the site
- Prioritize with site business lead the enterprise IT portfolio and local accountability for these global IT implementations
- Lead IT for site specific IT programs partnering with site process, business and data owners/lead.
- Responsible for the successful implementation and deployment of IT systems
- Coordinates Site Process Lead and with CoE’s, Cell Therapy IT and Quality on CSV for plant applications using IQ/PQ protocols.
- Provides IT Hypercare following deployment of plant applications
- Provides local support and/or first point of contact for enterprise systems such as ERP, LIMS, PLM, Robar, G&A applications.
- Partners with local Operations lead on supporting plant applications like MES/EBR, BMS with super user and system administration training for each release. Team to be able to basic maintenance configuration under guidance of Site Process owner.
- Provides support to local Quality, Supply Chain, PD IT systems and integrations with Manufacturing
- Vendor management for Managed Services support partners and/or local IT integrators partners.
- Provides IT Project Management for local implementations of Global Programs and/or development, configuration and implementation for local IT projects
- System Administration for enterprise applications at the site
- Communicate and facilitate upgrades and updates to enterprise systems impacting hardware and software
- Support IT and Systems audits.
Manufacturing Automation and Plant Infrastructure:
- Supports implementation and deployment of Manufacturing Automation Systems for integration with Enterprise systems.
- Implements plant infrastructure for Plant Application and access by end user devices (e.g., laptops, scanners, barcode readers, printers)
- Implements plant infrastructure to support Manufacturing Automation and connect to plant applications
- Provides secure connectivity between process control network and enterprise systems
- Commission IT rooms, network and server infrastructure
- Support of GMP and Non-GMP Network connectivity and servers
- Provides local support for on-site desktop, A/V, and Help desk, Lab computers, label printers, handheld mobile devices, scanners, etc.
- Provide key business partner to the global and regional heads of department to ensure platforms, processes and operation models are fit for purpose and providing escalation and information to the global team on areas
- Provide oversight, coaching and direction for IT staff in region as part of a matrix reporting structure.
- Work closely with Kite and Gilead IT peers and functions to ensure the right solutions provided for Cell Therapy in region
- Functional ownership and responsibility within the Maryland site of various Technical Operations and manufacturing system solutions to deliver CAR-T therapies to patients
- Setup and own a governance process to prioritize business capabilities and technology solution for site manufacturing
- Set direction and priorities for IT in region
- Work closely with IT leads in all manufacturing sites to prioritize and implement technology solutions
- Submit new capabilities and technology solutions with business justification and ROI to senior leadership team for approval
- Participate in annual budget cycle with finance, IT and manufacturing leadership team to submit budget requests for the new technology implementations in the roadmap
- Assist in evaluating vendor solutions, develop alternatives and recommend technical solutions in meeting the evolving needs of the business
- Lead and manage a team of highly skilled business analysts to deliver business capabilities through technology solutions.
- Understand short term and long-term data analytics and reporting requirements and recommend technology solutions for data warehouse and reporting.
- Project oversight as a stakeholder or participant as required
- BS/BA in Engineering, Biology, Chemistry or Computer/Information Sciences and 10 years of experience in GxP manufacturing environment supporting technology solutions -OR-
- MS/MA in Engineering, Biology, Chemistry or Computer/Information Sciences and 8 years of experience in GxP manufacturing environment supporting technology solutions -OR-
- PhD in Engineering, Biology, Chemistry or Computer/Information Sciences and 4 years of experience in GxP manufacturing environment supporting technology solutions
- Masters or Bachelor’s degree in Engineering, Biology, Chemistry or Computer/Information Sciences. MBA or any advanced certification will be a plus
- 8+ years of strong people management, leadership and team development skills.
- Experience in a GxP manufacturing environment supporting clinical and commercial manufacturing and corresponding technology solutions in a biotech/Pharma industry
- Experience in a Cell Therapy or any other personalized medicine in a make to order environment will be preferred
- Six Sigma Black Belt or similar qualification will be a plus
- Solid understanding of various project management methodologies to be accountable for large project implementations
- Excellent interpersonal, verbal and written communication and presentation skills and ability to interact and interface with all levels of business including senior leadership team
- Comfortable in a fast-paced small company environment with minimal direction, but also able to follow the processes and policies of large corporations.
- Solid understanding of various project management methodologies to own large project implementations.
- 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.