Scientist, QC Molecular

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 Bristol Myers Squibb is seeking a QC Senior Scientist for QC Molecular at the Cell Therapy Facility (CTF) in Leiden, the Netherlands. The QC Senior Scientist is responsible for performing as a subject matter expert in the completion of QC bioanalytical testing or data review for method validation, critical reagent qualification, in-process, release, and stability testing of clinical and commercial cell therapy drug product. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, troubleshoot, and lead complex investigations and CAPAs. Additionally, the QC Senior Scientist will be responsible for training and assay transfer. The QC Senior Scientist role is stationed in Leiden, and reports to the Director, QC Operations for the Leiden CTF. Key Responsibilities Subject matter expert in cellular and molecular biology techniques leading method transfer/validation and routine testing of in-process, final product, and stability samples. Use scientific principles to sustain and advance analytical testing methods and the proper use of laboratory equipment. Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner. Review all data in accordance with applicable procedures and cGMP requirements. Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs. Subject matter expert for training new analysts to general job duties. Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements. Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines. Own and evaluate relevant change controls, investigations, deviations, CAPAs. Conceptualize and lead complex projects and continuous improvement efforts. Communicate effectively with management and cross-functional project teams. Demonstrate initiative, courage, and continuous improvement throughout investigation/ corrective action lifecycles. Perform other tasks as assigned. Support for QC and manufacturing operations may include shift coverage consisting of on call, shift, and/or weekend coverage. Qualifications and Education Requirements Bachelor’s degree required, preferably in Science. Advanced degree preferred. 10+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment. 8+ years of advanced hands on experience with various bioanalytical techniques (cell based assays, ELISA, qPCR) and scientific knowledge in the characterization, validation and transfer of bioanalytical methods. Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. Advanced technical writing skills. Advanced problem-solving ability/mentality, technically adept and logical. Ability to represent the interests of the group on cross-functional teams. Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Advanced ability to communicate effectively with peers, department management and cross-functional peers. Ability to work with management locally and globally. Working knowledge of LIMS. 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.