Scientist I, Analytical Tech Transfer (Bioassays)

The Role:
ElevateBio is looking for a Scientist I to support the qualification, and transfer of cell-based and immunoassays from the Analytical Development teams to Elevatebio QC or external GMP labs. The position will work closely with the AD SMEs and the QC team and will also participate in method optimization and lifecycle management of assays. This is a highly visible, cross-functional role that will have the opportunity to impact numerous Cell and Gene therapy programs of Elevatebio.  

Here’s What You’ll Do:

• Execute and support the qualification of cell-based assays and immunoassays in close collaboration with the Elevatebio QC team, for the characterization and testing of viral vectors (Lentiviral vector, AAV), cell and gene therapy products and critical components.
• Execute, support, and manage transfer of analytical methods from the Analytical Development team to Elevatebio QC lab or external vendors.
• Collaborate with AD SMEs and the QC team to generate and approve protocols, reports, other technical documents required for the qualification and transfer of analytical methods.
• 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, and transfer of analytical methods to QC GMP labs is preferred. Knowledge of ICH/ regulatory guidelines for method qualification is desirable.
• Experience in a variety of cell-based potency methods plus techniques, e.g., Flow cytometry, ELISA, MSD, luminescence/ colorimetric plate-based assays 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.