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Our Client is looking for a Principal Associate Scientist to support the development and execution of novel molecular methods from the Analytical Development teams. The position will work closely with the AD SMEs, Analytical Testing Core and the QC team and will also participate in method optimization and lifecycle management of assays. This is a cross-functional role that will have the opportunity to impact numerous Cell and Gene therapy programs.

Here's What You'll Do:

• Execute and support the development, optimization and execution of molecular assays in close collaboration with the Analytical Testing Core and QC team, for the characterization and testing of viral vectors (Lentiviral vector, AAV), cell and gene therapy products and critical components.
• Collaborate with AD SMEs, Analytical Testing Core and the QC team to generate protocols, reports, other technical documents as part of test method development and optimization.
• Communicate with key stakeholders to work through potential challenges, troubleshooting, during qualification and method transfer activities.
• Provide necessary support during assay development as required. Participate in lifecycle management of assays, and implementation of new ideas and technologies.
• Provide support during investigations of relevant deviation incidents related to assay qualification or validation efforts.
• Analyze, interpret, and present data during team meetings and discussions.
• Form active collaborations and communicate with teams within Analytical Development, Quality, and other functions as well as external vendors.

Requirements:

• BS or MS in cell biology, molecular biology, biochemistry, or related sciences with a minimum of 4+ years (MS) or 6+ years (BS) of relevant and progressive experience in a Biotech setting.
• Experience in development/ qualification of analytical methods to QC GMP labs is preferred. Knowledge of ICH guidelines for method qualification/development is desirable.
• Experience in a variety of molecular technologies, e.g., ddPCR, qPCR, ELISA, is required.
• Knowledge or scientific background related to CGT products and viral vectors (e.g., Lentivirus, AAV) is a plus.
• Must have strong writing, and communication skills. Must have prior experience of authoring and reviewing protocols and technical reports.
• Good organization skills, multi-tasking, and ability to work in a cross-functional team environment is a must.

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