Stability Scientist, Regulatory Submissions (Global)

Biopharma Careers; Moreton; On-site; GBP 60,000 - 85,000; Full time

Job summary

Bristol Myers Squibb in Moreton, UK is seeking a Stability Scientist to join the Analytical Science & Operations team. You will act as the stability expert across CMC, ensuring product integrity from development to submission and maintaining audit readiness.

The role involves writing stability protocols, engaging with global regulators, and analyzing stability data trends. 3–5 years of GMP pharmaceutical experience and strong data storytelling are required.

Qualifications

• 3–5 years of pharmaceutical industry experience, ideally in a GMP environment.
• Solid working knowledge of ICH guidelines and regulatory stability expectations.
• Strong written communication skills - you can turn complex data into clear, compelling scientific narratives.
• Familiar with Microsoft Office, and ideally systems like Veeva or LIMS.
• Exposure to AI tools, statistical or modelling software is a bonus.

Responsibilities

• Act as the stability expert that CMC teams turn to for guidance, keeping projects moving.
• Write and approve stability protocols and reports to support regulatory submissions for small and large molecule therapies.
• Engage with global regulatory agencies, authoring responses and representing BMS in meetings as needed.
• Analyse trends in stability data, raise flags at the right time, and address unexpected results.
• Shape ways of working by evaluating and implementing changes to stay aligned with regulatory expectations.
• Maintain audit readiness and contribute to a culture of quality and compliance.

Skills

Analytical chemistry knowledge

GMP experience

Regulatory stability knowledge

Strong written communication

Independent work

Education

Analytical Chemistry / Chemistry / Biochemistry degree (B.S. minimum)

Tools

Veeva

LIMS

Microsoft Office

Job description

Bristol Myers Squibb in Moreton, UK is seeking a Stability Scientist to join the Analytical Science & Operations team. You will act as the stability expert across CMC, ensuring product integrity from development to submission and maintaining audit readiness.

The role involves writing stability protocols, engaging with global regulators, and analyzing stability data trends. 3–5 years of GMP pharmaceutical experience and strong data storytelling are required.