At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
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 Senior Process Engineer is responsible for supporting the transfer and implementation of the CAR-T manufacturing process for personalized cell therapy products for both clinical trials and commercial supply. Collaborates with SMEs from the Development, Manufacturing, Quality and other internal and external parties, while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement and support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
This position is based in Leiden, the Netherlands. Occasional traveling for training purposes might be required.
Key Responsibilities
- Develop and continuously improve processes to ensure timely product disposition; manage the lot disposition Maintain permanent inspection readiness and actively support regulatory inspections
- Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
- Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production
- Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
- Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
- Sponsor and support the change initiatives and the implementation of process improvement initiatives
Qualifications & Experience
- Minimum 8 years of experience in manufacturing or MSAT role
- Expert knowledge of cell therapy regulations.
- Deep knowledge of facility/clean room design, process, equipment, automation, and process related materials
- Experience to work in a start-up facility environment and ability to set up the process in the new facility
Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.
Why You Should Apply
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.