Manager, CMC Documentation

At Bristol Myers Squibb our employees often ask Who are you working fora 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 doesnt have to stay in the lab to make a difference.

Theres a pivotal moment in the life of every medicine - when the science thats 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 were 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

Youll 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 youll 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 thats 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: youll be the person who takes brilliant science and makes it legible defensible and submission-ready for medicines that are working their way toward patients.

Whats genuinely in it for you

• Rare breadth across molecule types Small molecules. Biologics. ADCs. Working across all three is genuinely unusual and genuinely valuable. Youll 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 Youll 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 - thats a sophisticated senior-level skill set that this role actively builds.
• Ownership of work that determines what gets approved CMC documentation isnt peripheral to the regulatory process - its central to it. Your documents will be reviewed by health authorities around the world. The care precision and scientific judgement you bring to them directly shapes whether - and how quickly - a medicine advances. Thats a meaningful level of ownership for someone at this stage of their career.
• The chance to apply your scientific mind differently If youve spent years in the lab and found yourself drawn to the bigger picture - to the question of how science becomes medicine at a regulatory and strategic level - this role is a compelling answer to that pull. Your scientific background isnt left behind; it becomes the foundation for a different kind of impact.
• Cross-functional visibility that accelerates your career Youll work closely with teams across the entire drug development spectrum - from early process chemistry to regulatory strategy to clinical supply. That breadth of exposure and the relationships it builds gives you an organisational understanding that few roles at this level can offer.
• Craft that matters Great regulatory writing is a skill - and at BMS its valued. If you take genuine pride in written communication in finding exactly the right way to explain a complex technical concept to an expert audience this is a role where that craft is not just appreciated but essential.

Is this you

• Youll hold a degree in organic chemistry biological sciences biochemistry pharmaceutical sciences or a related discipline - and bring at least 5 years of pharmaceutical development experience involving small molecules biologics and/or ADCs.
• Your scientific knowledge is solid enough to engage credibly with development scientists across multiple disciplines. Your written and verbal communication skills are genuinely excellent - not just competent. You work constructively in cross-functional teams bring critical analysis and scientific judgement to problem solving and hold yourself to a high standard of accuracy.
• Familiarity with computer-assisted document preparation tools is a real advantage. Above all you understand that in regulatory submissions the detail is everything - and that suits you just fine.

Why BMS why now

BMS has one of the most innovative and diverse pipelines in the biopharmaceutical industry - spanning oncology immunology cardiovascular disease and beyond. Our Moreton site is a key part of that global operation home to experienced expert teams doing technically sophisticated work that directly supports our drug development programmes.

As our portfolio of small molecules biologics and ADCs continues to grow the demand for high-quality scientifically rigorous CMC documentation has never been greater. This role sits right at the centre of that need - and at the centre of our mission to deliver transformative medicines to the patients who need them most.

If this sounds like the role youve been looking for wed love to hear from you.

#LI-Hybrid

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

How We Work

Where you work matters because collaboration innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential site-by-design field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at People with Disabilities

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