Senior Scientist I/II, Analytical Development and Validation

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. Minimum Requirements: 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.

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