Project Manager MES (Implementation)
Our client, 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. With an unrelenting drive and a singular focus on cell therapy, the Kite team is executing on their strategy to bring life-saving therapies to patients.
There is an immediate need to on-board an IT Program Manager to support the development and oversight of the Global Manufacturing Execution System (MES) Electronic Batch Record (EBR) program and roadmap. The program/roadmap will consider all of Kite's existing and planned Manufacturing Sites. In addition to the application itself, scope would include (but not limited to) the required infrastructure, disaster recovery, peripheral systems, business processes, change management, operationalization and support model required for the successful implementation, deployment and support of MES EBR to all required sites.
The position is a 6 - 12 month contract opportunity for a highly experienced IT Program Manager based at the manufacturing site. The candidate will work with MES program manager in the US as well as technical and business project stakeholders to define and execute site specific tasks related to the successful delivery of the Global MES EBR program tailored to the TCF04 manufacturing site.
As the MES Implementation Project Manager, the candidate will have oversight of the MES program at the local level as it pertains to the rollout of MES at TCF04. The project manager will work closely with the local and global project teams to drive governance, structure and alignment across the program.
The candidate will be the key point of contact to ensure that interdependencies are tracked and risks escalated in a timely manner to the correct stakeholders. The candidate will report on the status of all workstreams, the interdependencies and the risks as they pertain to the manufacturing site.
Skills and Mastery Requirements:
Soft skills: Cross-functional team leadership, strong communication skills, emotional intelligence and ability to work effectively in a global environment (strong multi-cultural team collaboration skills).
* Project Management professional fluent with waterfall, critical path management, agile (scrum, kanban) frameworks and tools. Hands-on experience with the modern collaboration tools.
* Experience of successful technical solution implementation projects in Supply Chain or Manufacturing. Working knowledge of SDLC.
* Experience in Pharma or other regulated industries is highly desired.
* Relationship management and networking
Technical Mastery: IT or process automation background desired, experience with MES applications is highly desired, basic understanding of web applications, SOA, relational databases and virtualized infrastructure is required. Pas-X implementation experience is a big plus.
Objective: be accountable for the overall successful delivery of MES and associated business cases at the Site.
* Own the development of business cases for MES implementation, project charter and success criteria
* Develop project scope and schedule and execute on-going change management of both. Ensure regular integration of the project timeline into Global Program timeline and the Site Start-up program, manage local and milestone dependencies
* Assemble, secure and develop cross-functional site team, manage local vendors involved in delivery of the project work, coordinate task / work between site and remote resources
* SPOC for local stakeholders and Global Program team on MES, manage regular site communication and project documentation. Build project relationships between Site teams and global teams including CoE, IT Platform, Osi Pi, PD, Corporate QE.
* Deliver full project scope that includes Discovery phase (requirements engineering), implementation of electronic batch management for Yescarta manufacturing in a phase-based approach, integration with L2 systems per ISA-95 standard, integration with EBS, Site computer system validation, setup and delivery of the Site MES training program, execution of the Organization Change Management and transition to Sustainment.
* Execute Site project budget management, deliver monthly 10% forecast accuracy. Drive the development of SOWs for Site project tasks and ensure the execution of commercial processes to support the delivery of vendor commitments.
* Setup the structure for estimating and tracking benefits of MES implementation
* Accountable to implement best practices from the IT PMO for project budget management and reporting.
* Project meets established success criteria
* Value Creation Goals Achieved By Project as defined in business case
* System Utilization / Adoption
Pas-X (3.1.18), Osi Pi, Historian, Kepware, Oracle EBS
Send your cv via the link, contact Marc Philip van Ittersum for more info. 0654712600
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