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.