Reports To: Head, Global Biologics MSAT and Global Packaging Development
Organizational Function: Global Biologics Manufacturing Science and Technology
Location: South San Francisco or Basel
? The Roche Enterprise Manufacturing Intelligence (REMI) Project lead and Business Owner (BO) is responsible for development and sustainment of a data acquisition and analysis solution for the Roche Manufacturing Network. This position is part of the Global Biologics Manufacturing Science and Technology (GBMSAT) team. As the owner of the REMI system, the individual is responsible for ensuring the tool meets business needs of the Roche manufacturing network.
? The REMI BO will work with business leaders and technical experts across the Roche Pharma Technical (PT) Operations network and will be responsible for leading and sustaining the REMI project across PT, including Small and Large molecules operations. Specifically, the BO will be accountable for delivering a scalable software solution to acquire, organize, analyze and report product and process data from manufacturing operations. It is expected that this program will expand to enable real-time visual analysis of manufacturing operations, and use of advanced statistical methods to assess process and product health.
? The candidate will be required to build and manage the global REMI project team. The Project Lead will lead execution of this project in accordance with approved timelines, milestones, and budget (~$10M annually). This will require the candidate to have previously demonstrated strong leadership and management skills, such as rapid decision-making, objective prioritization, strong communication and influencing skills, and strategic agility. In order to deliver the necessary value to the organization, candidate will collaborate with manufacturing, quality, and data management experts across PT.
? Lead the REMI project across the Roche Manufacturing network to develop and build an automation solution that will ensure the Roche network remains compliant with Health Authority (HA) expectations and compliance standards
? Collaborate with Roche network leaders and industry technical experts to manage overall program vision and develop the implementation strategy.
? Collaborate with network technical experts to align network business processes and data standards that will minimize project complexity. Apply LEAN principles as needed to simplify project execution.
? Utilize Pharmaceutical Industry standards to support the Roche vision for Continued Process Verification. Serve as a Roche expert for implementation of global computer systems to provide continual assurance Roche manufacturing process remains in a validated state using statistical methods.
? Collaborate with the Process and Product Monitoring BPO to continuously improve the ongoing assessment and visualization of Roche product and operations health. Lead the development and support of both GMP and non-GMP computer systems to streamline Roche process monitoring and analysis.
? Work with IT SMEs on the project team to address complex data integration issues. Be able to interface with 3rd party vendors to assemble a robust data architecture and to incorporate external software solutions as needed.
? Lead a global team comprised of Manufacturing, Global Automation/Information Technology and Quality, to realize REMI project objectives. Demonstrated ability to establish functional or project teams, setting team strategy, goals, and implementation plans to enable project execution and maintain momentum.
? Proactively maintain working relationships with Business Leaders in PT to integrate their needs into project execution.
? Collaborate with REMI users to support the change management process, ensure successful software deployment, and customer satisfaction. Provide clear written and verbal communication of project goals and accomplishments across stakeholder groups, at various levels of management, internal and external to Roche.
? Responsible for developing, monitoring, and achieving project budget goals. Works with REMI project PMs to meet project schedule and budget
Who You Are
? A Bachelor, Master, or Doctorate degree is required. A degree in Engineering (ex. Chemical, Electrical, Mechanical) or equivalent training is preferred with at least 12-15 years of related industrial and/or academic experience after receiving Bachelor’s degree. Prior people management experience is required.
? Demonstrated work experience specific to automation design, implementation and/ or support of automated control systems. A working understanding of Good Automated Manufacturing Practice (GAMP) as it applies to automation design, implementation, and testing, and a working understanding of computer system validation principles is beneficial.
? Demonstrated experience in leading complex projects and managing project teams, experience leading remote/cross-site teams
? Experience with statistical analysis techniques used in process monitoring, modeling and data management and knowledge of commercially used databases and data structures is beneficial
? Experience with computer systems used to control and monitor routine, large-scale pharmaceutical manufacture (e.g., Process Control Systems, Manufacturing Execution Systems, Enterprise Resource Planning Systems, Laboratory Information Management Systems).
? Strong written and oral communication skills; comfortable presenting to a Senior Management/Executive Level stakeholders
? Some domestic and international travel
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
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