Manager, CMC Documentation

Bristol-Myers Squibb Co; Moreton; On-site; GBP 90,000 - 120,000; Full time

Job summary

Bristol Myers Squibb in Moreton, UK is seeking a Manager, CMC Documentation & Specifications to join the Analytical Strategy & Operations team. You will author and coordinate CMC sections of regulatory submissions across small molecules, biologics, and ADCs, driving precision and regulatory fluency.

The role emphasizes high‑quality regulatory writing, cross‑functional collaboration, and rigorous data verification to support global submissions and timely approvals.

Qualifications

• Degree in organic chemistry, biological sciences, biochemistry, pharmaceutical sciences, or a related discipline.
• At least 5 years of pharmaceutical development experience involving small molecules, biologics, and/or ADCs.
• Strong written and verbal communication skills with ability to communicate with precision and regulatory fluency.

Responsibilities

• Authoring CMC regulatory documents–translating complex scientific data into precise, submission-ready content meeting global standards.
• Leading specification activities for small molecules and ensuring regulatory compliance.
• Coordinating responses to Health Authority inquiries with accurate, timely, scientifically sound replies.
• Verifying data with scrupulous attention to detail to ensure submission robustness.
• Proactively identifying concerns and flagging potential issues before submission problems arise.
• Collaborating across the organisation with multiple development and regulatory teams.

Skills

Regulatory writing

CMC documentation

Cross-functional collaboration

Regulatory fluency

Attention to detail

Education

Degree in organic chemistry or related discipline

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 builds.
• Ownership of work that determines what gets approved – CMC documentation isn't peripheral to the regulatory process – it's central to it. Your documents will be reviewed by health authorities around the world. The care, precision, and scientific judgment you bring to them directly shapes whether and how quickly a medicine advances. That's a meaningful level of ownership for someone at this stage of their career.
• The chance to apply your scientific mind differently – If you've 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 isn't left behind; it becomes the foundation for a different kind of impact.
• Cross‑functional visibility that accelerates your career – you'll 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, it's 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?

You’ll 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 you've been looking for — we'd love to hear from you.

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 https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS is Disability Confident – Employer A UK Government scheme. Candidate Rights BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application‑related inquiries to this email. To check your application status, please login to your Candidate Home Account.

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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.