Sr. Manager Life Cycle Management

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 This function is part of the MSAT department and reports to head of MSAT to. This role is responsible for managing the process changes aiming for continuous improvement during and post TT. The incumbent is responsible for technical and strategical overview and planning of process changes during TT and after submission and acts as the Point of Contact between MSAT ,QA, QC and RA. This function is responsible to lead the implementation of changes and improvements for the products by engaging local departments as well as communicating with functional teams based in different geographic areas. The Life Cycle Management role, owns and provides strong technical oversight of our commercial products and End to End processes throughout their life cycle and represents MSAT in the audits and during submission activities. This job requires occasional traveling. Key Responsibilities Responsible for leading the implementation of process changes and improvements based on the business strategic need Guarantee the definition and follow up of the implementation strategies of variation/changes (tell&do changes), in order to ensure supply continuity in the market and geographic expansion when requested Responsible of leading multidisciplinary taskforce, complex projects in order to support technical lifecycle management and continuous improvement. This responsibility includes the preparation of business case and overall budget definition, implementation of efficient governance, monitoring of project progress and escalation to appropriate governing bodies. Responsible to support the MSAT team and prepare a Life Cycle Management Plan for the products manufactured on the site Responsible to feed and maintain the knowledge management for the products and to ensure continuous exchange and update with the production units and with the Quality network Responsible to give the product/process/quality inputs for the product variation roadmap. Support providing inputs related to testing strategy and represent and interface with the sites to assure understanding/alignment of product strategy (in collaboration with Global MSAT) Responsible for considering outcome of the continued process verification within the product maintenance strategy Experience: Advanced degree in process engineering sciences, and/or academic level in life sciences in general (biology, biomedical science, pharmacist, chemistry). Minimum 7 years applicable experience in biological manufacturing and / or experience in QA, QC, R&D within a biological environment Excellent in Data analysis and IT tools Solid understanding of technologies used in cell-based processes, preferably cell therapy processes Experience with ICH – FDA – EU and RoW guidelines about product Life Cycle Management as well as Comparability principles, protocols and reports to be issued when pre-post changes have to be evaluated 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.