Senior Director, CMC Team Leader

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. At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, cardiovascular, and neuroscience 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. The Scientific Director, CMC Team Leader is responsible for developing and leading the execution of comprehensive, compound-specific CMC strategies to meet global R&D project needs. Supporting the Product Development portfolio, which includes small molecules, large molecules and new modalities (conjugates, peptides and oligonucleotides), this unique role is critical to our role turning molecules into medicines. Primary responsibilities of the Scientific Director, CMC Team Leader: * Leads the interdisciplinary matrix teams responsible for developing and executing compound-specific integrated CMC strategies that advance R&D Project Team objectives and encompass drug substance, drug product, analytical, quality, regulatory, and clinical supplies. * Represents the Global Product Development and Supply (GPS) organization on key R&D Project Teams, actively collaborates across functional areas (Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, etc.) and influences the BMS organization to develop globally optimized program strategies. * Communicates and partners effectively across functional areas within Product Development and other stakeholders (Quality, Toxicology, DMPK, Clinical Pharmacology, Regulatory CMC, Commercial Manufacturing, etc.) to define and execute the CMC strategy for the project. Identifies and escalates key issues, risks and resource allocation needs, as appropriate * Accountable for managing multiple assets across large and small molecules, ranging across phases of development from candidate nomination, First-in-Human, and pivotal clinical studies, through to market application approvals (BLA, NDA) in partnership with CMC Team Project Manager. * Accountable for CMC Project budget and applies financial acumen to evaluate portfolio trends and anticipate the impact of strategic inflection points on project trajectories. Works with a ‘return on investment’ mindset to define project opportunities, seeking to optimize PDs impact within the broader portfolio. * Influences CMC regulatory strategies and critically reviews relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, and information requests. * Champions operational excellence by driving the adoption of best practices and spearheading strategic improvement initiatives, including the adoption of advanced digital capabilities, planning tools and program simulation. Partners with the GPS Business Development group to support Due Diligence evaluations and activities to bring assets into the GPS network and partner with alliance management, as...