About This Role
This Research & Development Scientist role focuses on delivering high-quality, compliant analytical data to drive product development within a pharmaceutical R&D setting. The scientist will take ownership of stability programmes and contribute to the successful development and scale-up of innovative products, working independently to design, execute, and manage stability studies.
Responsibilities
- Lead the design and management of stability studies (ICH, stress, transport) and ensure all pulls, testing, and reporting are delivered to schedule
- Author, review, and maintain specifications for starting materials, packaging, and finished products
- Generate, review, and approve stability protocols, sampling plans, reports, and shelf-life justifications
- Provide technical support for technology transfer and scale-up activities
- Coordinate testing with external laboratories, ensuring efficient communication and adherence to timelines
- Review and approve analytical data for release and stability compliance
- Perform trend analysis and statistical evaluation of stability data, identifying risks and opportunities
- Lead investigations, supplier non-conformances, and quality events
- Author stability sections for regulatory submissions (e.g., CMC)
- Contribute as a technical representative during audits
- Uphold site quality, health & safety, and product safety standards
Requirements
- Experience working within a GMP environment
- Strong communication and interpersonal skills
- Excellent organisational ability and confidence working independently
- Practical experience with method development/validation using techniques such as ELISA, SDS-PAGE, DUMAS, FT-IR, immunoassay, immunoblotting, electrophoresis, HPLC, UV, FTIR, and LC-MS
- Experience performing statistical analysis of analytical data
- BSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or equivalent experience
- Already hold permanent, unrestricted right to work in the UK
Important Details
- Schedule: 60% office based, 40% lab based
- Contract: permanent
About the Company
Our client is a growing pharmaceutical company focused on product development.