SKILLS

Analytical methods GLP GMP Product specifications Validation reports Technical reports Data interpretation Laboratory science

FULL DESCRIPTION

Analytical Research & Development Scientist

Location: Leeds, West Yorkshire (site based)

Key Responsibilities

• Independently develop, validate and transfer analytical methods (including dissolution methodology) that will adequately determine the necessary product characteristics that will eventually be required to release drug product and to monitor the storage stability of new products.
• Conduct physical and chemical testing on prototype formulations to assess stability and assign provisional shelf life, ensuring full compliance with GLP and, where applicable, GMP requirements for documentation and review.
• Create and review product specifications, analytical methods, and process documentation, recommending improvements as new technologies and techniques emerge.
• Prepare and review validation reports, analytical methods, COSHH assessments, SOPs/WRKs, and scientific protocols, ensuring documentation meets company and regulatory standards, and support regulatory submissions (CTD Module 3) by generating data and responses for regulatory RFIs.
• Participate in cross‑functional project teams, leading technical discussions, fostering strong interdepartmental relationships, promoting departmental objectives, and staying current with scientific advancements to ensure products, processes, and analytical methodologies reflect best practice.
• Successfully investigate and resolve moderately complex analytical problems, project issues and deviations.  Accurately maintain all related documentation in compliance with written procedures.

Knowledge, Experience and Skills

• A degree in a laboratory‑based science (or equivalent).
• Minimum GCSE grade A–C (or equivalent) in Mathematics and English.
• Proven experience with a range of analytical instruments and software used for physical and chemical analysis.
• Ability to work independently across multiple concurrent projects and develop testing plans that significantly enhance product understanding.
• Ability to maintain high‑quality documentation, interpret data effectively, and prepare technical reports as required.
• Ability to develop, document, and execute analyses or experiments of moderate complexity.