Manager, CMC Documentation at Bristol Myers Squibb in Moreton

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Your scientific expertise doesn't have to stay in the lab to make a difference. There's a pivotal moment in the life of every medicine - when the science that's been developed, tested and refined has to be translated into something a global health authority can evaluate, scrutinise and ultimately approve. That moment depends entirely on the quality of the documentation that tells the story. Get it right, and a treatment moves closer to the patients who need it. Get it wrong - or get it late - and the consequences ripple across trials, timelines and lives. At Bristol Myers Squibb , we're looking for a Manager, CMC Documentation & Specifications to join our Analytical Strategy & Operations team in Moreton, UK. This is a role for a scientist who loves the science — but who also has the rare ability to communicate it with precision, clarity, and regulatory fluency. So what does this role actually involve? You'll work at the heart of our Chemistry, Manufacturing, and Controls (CMC) regulatory process, authoring and coordinating the CMC sections of regulatory submissions - INDs, CTAs, NDAs, BLAs - across our portfolio of small molecules, biologics and antibody-drug conjugates (ADCs) . That means you'll be: Authoring CMC regulatory documents - translating complex scientific data from across multiple development disciplines into precise, well-structured, submission-ready content that meets global regulatory standards and project timelines Leading specification activities for small molecules - taking ownership of a technically critical area that sits at the intersection of development science and regulatory compliance Coordinating responses to Health Authority inquiries - assembling accurate, prompt and scientifically sound technical responses to questions from global regulators, where the quality of your answer can determine whether a review moves forward or stalls Verifying data with scrupulous attention to detail - ensuring that what goes into a submission is not just accurate, but demonstrably, rigorously accurate, because that's what regulatory trust is built on Proactively identifying concerns - reviewing content from scientists and CMC teams with a critical eye, flagging potential issues before they become submission problems Collaborating across the organisation - working in close partnership with Chemical Process Development, Biologics Development, Drug Product Development, Manufacturing Science & Technology, Clinical Supply Operations, Nonclinical Safety, Global Regulatory Sciences, Asset Leadership and Portfolio Sciences In short: you'll be the person who takes brilliant science and makes it legible, defensible, and submission-ready — for medicines that are working their way toward patients. What's genuinely in it for you? Rare breadth across molecule types Small molecules. Biologics. ADCs. Working across all three is genuinely unusual, and genuinely valuable. You'll develop regulatory and scientific fluency across some of the most technically complex and commercially important modalities in modern drug development - knowledge that is highly portable and increasingly in demand. Global regulatory exposure You'll be engaging with regulatory submissions and Health Authority inquiries that span international markets. Understanding how different global agencies think, what they ask, and what they need to be convinced - that's a sophisticated, senior-level skill set that this role actively