Manager, Process Engineer

Bristol-Myers Squibb; Netherlands; On-site; EUR 120,000 - 160,000; Full time

Job summary

Bristol Myers Squibb Netherlands in Leiden seeks a Manager Process Engineering to lead the CAR-T production for clinical trials and commercial supply in a 24/7 operation. The role manages the Process Engineering team, collaborating with SMEs from Process Validation, MES/Automation, Manufacturing, and Quality to ensure rapid, compliant, and cost-effective delivery of quality products.

You will provide on-site and on-call support, lead investigations and deviations, drive change and

Qualifications

• Lead Process Engineering activities for CAR-T production.
• Collaborate with Process Validation, MES/Automation, Manufacturing, and Quality.
• Ensure timely, compliant delivery of high-quality therapies.

Responsibilities

• Drive end-to-end process monitoring and optimization.
• Lead investigations and deviations ensuring regulatory compliance.
• Provide on-site and on-call support during operations.
• Coordinate change initiatives and process improvements.
• Collaborate with cross-functional teams including Manufacturing, QA and Supply Chain.

Skills

Process Engineering

CAR-T manufacturing

Regulatory compliance

Cross-functional collaboration

Job description

At Bristol Myers Squibb, our employees often ask, \"Who are you working for?\"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Bristol Myers Squibb Netherlands

Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands.

The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it!

The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team.

Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer!

For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl

Position Summary

The Manager Process Engineering is responsible for implementing and supporting the production of CAR-T cell therapy products for both clinical trials and commercial supply as part of 24/7 operations at Leiden facility. The Manager Process Engineering is responsible for managing activities in Process Engineering team from a technical perspective. The Manager Process Engineering collaborates with SMEs from Process Validation, MES/Automation, Manufacturing, and Quality to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.

Duties/Responsibilities:

• Drive the processes to continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production including Process Equipment System support and troubleshooting


• Provide technical input and guide lead investigators for process related investigations, including leading high criticality deviations ensuring compliance with internal standards and regulatory requirements.


• Drive and ensure technical documentation is reviewed and approved on time by MSAT PE department (e.g investigations, changes, SOPs, batch records, protocols and reports)


• Provides on-site and on-call support during operations and any process related topics coming from shopfloor and front-line support.


• Guide implementation of change initiatives and process improvement initiatives


• Interact with manufacturing, quality control, supply chain, facility & engineering, and quality assurance SMEs and leaders and serve as processes SME for the multiproduct facility.


• Interact with SMEs in the BMS Cell Therapy network.


• Drive internal collaboration with other MSAT functions for data collection, analysis, and interpretation of data and drive collaboration with cross-functional teams including Manufacturing, Quality Assurance and Supply Chain.


• Guide and provide input for preparations for regulatory inspections and support regulatory inspections. Ensure that all actions linked to MSAT process engineering are executed as per agreed timelines.


• Lead interactions with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs.


• Coordinate and prioritize initiatives to ensure that risks from manufacturing operations that could negatively impact delivery of safe effective therapies to patients are identified and mitigated proactively. Accountable for ensuring the continuous optimization of the process.


• Manages project teams, coordinates the execution of technical projects and develops presentations to disseminate results to project stakeholders and senior management.


• Oversees campaign readiness activities with a cross-functional team to ensure flawless production campaigns.


• Ensure execution of test plans and other risk mitigation exercises as part of complex (major and critical) investigations (e.g. Root cause analysis and CAPAs for OOS or batch termination).


• Lead OOS investigations and act as Process Technical SME (including MRB)


• Foster strong inter-team relationships to achieve common project goals.


• Lead the tracking of team metrics and manage completion of objectives and projects


• Ensuring on time closure of Product/Process impact assessments, PQEs, CAPAs, and change controls. Perform p