Manager, Process Engineer

Job description

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. 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 process data monitoring. Create an environment of teamwork, open communication, and a sense of urgency, promoting flexibility, creativity, and accountability. Support organizational strategic goals and objectives that are linked to the overall company strategy Build trust and effective relationships with peers and stakeholders Foster a culture of compliance and strong environmental, health, and safety performance Support transition from technology transfer phase to commercial routine manufacturing, including Ramp and Training. Qualifications: Deep knowledge of facility/clean room design, cell therapy processes, equipment and automation. Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies. Experience working with external parties and/or leading cross-functional teams. Possess strong verbal/written communication skills and ability to influence at all levels. Expert knowledge of cGMP’s and biopharmaceutical/cell therapy regulations. Capable of working well as a people manager and in a matrix environment, collaborating and guiding Process Engineering team and stakeholders. Ability to perform process and hands on troubleshooting, independent thinking and decision-making capability. Ability to think strategically and to translate strategy into actions. Experience in process change controls, complex deviations root cause analysis and impact assessment complying to quality systems requirements. Experience with Operational Excellence and Lean Manufacturing. Education/Experience/Licenses/Certifications: Bachelor’s degree in relevant science or engineering discipline, or equivalent in work experience. Advanced degree preferred. Knowledge of Lean Manufacturing principles required. Minimum of 8 years of experience in cGMP biologics manufacturing, preferably in cell therapy in manufacturing or MSAT roles Travel: Occasional Travel may be required for this position. #LI-Onsite 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 com