Senior Scientist I/II, Analytical Development and Validation

We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you. 

We are currently recruiting for a Senior Scientist I/II to join the Analytical Development and Technology group.  This role requires a seasoned professional to lead and manage analytical projects (CMC) encompassing assay development, qualification, validation, and QC implementation for testing lentiviral vectors for cell and gene therapies from early to late-stage clinical development. The successful candidate will support team members and ensure the timely and high-quality delivery of team goals and client work packages.  

Your responsibilities in this role would be:  

• Lead the development, transfer, qualification, and validation of assays for testing lentiviral vectors to support characterization, release and stability testing (GMP). 

• Manage and deliver client work packages, maintaining proactive coordination and communication with clients, internal project managers, AD team members and other departments, under supervision from Group Leads. 

• Author and review technical documents, including qualification/validation plans, study documentation, reports, risk assessments and SOPs. 

• Act as a Subject Matter Expert (SME) for analytical methods such as cell-based, qPCR/ddPCR, ELISA, and HPLC, providing scientific and technical guidance, troubleshooting, and contributing to client discussions. 

• Contribute to regulatory documents for CMC analytical sections of clinical trial applications (IMPD, IND) and marketing authorizations (MAA, BLA), in accordance with ICH and regulatory agencies guidelines. 

• Ensure robust technical transfer of methods to QC (Quality Control) and other departments/sites. 

• Ensure a high standard of record keeping and documentation of experiments and investigations in order that information is clearly captured, disseminated and reported, from good research practices to GxP standards. 

• Drive innovation in assay lifecycle management and contribute new ideas to enhance viral vector analysis within the team and organization. 

• Contribute to continuous improvement projects to increase efficiency of the team activities. 

• Support and mentor other scientists within the department.  

We are looking for:  

• BSc, MSc or PhD in a Biosciences field or similar. 

• Knowledge and laboratory experience in two or more of the following assay types: cell-based assays, qPCR/ddPCR, molecular biology, ELISA or HPLC. 

• Experience in managing and delivering scientific/technical projects to defined objectives and timelines in a busy environment. 

• Experience in liaising and communicating with different stakeholders such as adjacent teams/departments, external partners, clients or collaborators is an advantage. 

• Experience in working or being exposed to a regulated GxP environment is strongly preferred. 

• Knowledge/experience in virology and/or gene therapy products is an advantage.  

• Understanding of basic statistics in experimental data analysis and/or AQbD/DOE. 

• Competency in data capture, documenting and reporting scientific/technical studies.  

• Ability to work accurately in a busy and demanding environment, and to manage competing priorities.  

• Credible and confident communicator (written & verbal). 

• Self-motivated with the ability to work proactively using own initiative.  

• Demonstrates ability to work well in a team as well as independently. 

• High level of familiarity with Microsoft Office.  

Collaborate. Contribute. Change lives