Stability Scientist: Regulatory Submissions & Data Insight

Bristol-Myers Squibb; Moreton; On-site; GBP 60,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits

Growth opportunities

Supportive culture

Global exposure

Job summary

Bristol Myers Squibb’s Analytical Science & Operations team in Moreton, UK, seeks a Stability Scientist. This role focuses on safeguarding product integrity across drug substances and products, with data-driven decision making and regulatory alignment.

You'll interact with CMC teams, write stability documents, and support international submissions, contributing to a robust quality culture while advancing therapies for patients.

Qualifications

• Degree in Analytical Chemistry, Chemistry, Biochemistry, or related (B.S. minimum).
• 3–5 years of pharmaceutical industry experience, GMP environment preferred.
• Solid knowledge of ICH guidelines and regulatory stability expectations.
• Strong written communication skills; ability to translate data into clear narratives.
• Independent, able to manage timelines and elevate when needed.

Responsibilities

• Write and approve stability protocols and reports supporting regulatory submissions for small and large molecules.
• Serve as stability expert to guide CMC teams and keep projects moving.
• Engage with global regulatory agencies; respond to questions and represent in meetings.
• Analyze trends in stability data; flag issues early and drive appropriate actions.
• Shape processes to stay aligned with evolving regulatory expectations and industry best practices.
• Maintain audit-ready culture and contribute to quality and compliance.

Skills

Analytical Chemistry

GMP

ICH Guidelines

Regulatory Stability

Documentation

MS Office

Veeva/LIMS

Education

B.S. in Chemistry

Tools

Veeva

LIMS

Job description

Bristol Myers Squibb’s Analytical Science & Operations team in Moreton, UK, seeks a Stability Scientist. This role focuses on safeguarding product integrity across drug substances and products, with data-driven decision making and regulatory alignment.

You'll interact with CMC teams, write stability documents, and support international submissions, contributing to a robust quality culture while advancing therapies for patients.