ROLE OVERVIEW

An exciting opportunity for a Senior Analytical Development Scientist to join a leading biotechnology company based in Oxfordshire. This role offers a chance to contribute significantly to the development, qualification, and validation of analytical methods supporting drug substance and drug product evaluations from preclinical through late-phase clinical development, ensuring compliance with regulatory standards.

Working within a collaborative environment, you will play a key role in supporting product release, process development, and characterization, while coordinating analytical activities across external partners such as CMOs and CROs. This position is ideal for an experienced scientist looking to make a tangible impact on cutting-edge biopharmaceutical advancements.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Senior Scientist, Analytical Development will be varied however the key duties and responsibilities are as follows:

• Manage the development, qualification, and validation of analytical test methods, cell based assays and oversee technology transfer in line with regulatory guidance such as ICH.
• Support release, stability testing, and GMP investigations including root cause analyses, CAPA, and OOS assessments both in-house and at external CROs.
• Develop strategies for evaluating and implementing new analytical technologies within the department.
• Support process development activities, including setting specifications, regulatory filings, and responding to questions from authorities.
• Provide expert input during method troubleshooting, data analysis, and cross-functional meetings with manufacturing, QA, Regulatory Affairs, and external partners.
• As the Senior Scientist, you will supervise Assay Development Scientists or Technicians and ensure timely, quality deliverables.