Scientist I, Analytical Development

The Role:
ElevateBio is looking for a Scientist, Analytical Development to lead the optimization, transfer, and execution of analytical methods for the characterization and testing of mRNA, oligos, LNPs, and other cell and gene therapy products and critical components. The position will perform sample testing to support the process development of critical components and drug product. This position that will work cross-functionally with PD, Quality, Regulatory, and Manufacturing teams of ElevateBio, as well as external partners.

Here’s What You’ll Do:

• Develop/ Optimize and transfer analytical methods for the characterization of mRNA drug substance and mRNA-LNP drug product.
• Execute sample testing to support the mRNA and LNP process development.
• Support the qualification of analytical methods per ICH guidelines as required.
• Stay informed on the regulatory guidance for mRNA drug development and provide expertise in mRNA regulatory strategy.
• Collaborate with external partners, clients to lead/ monitor development activities, and ensure deliverables in a timely manner.
• Author and review technical reports, protocols, and relevant sections of regulatory filings. Maintain electronic lab notebooks and data records.

Requirements:

• M.S. or Ph.D. in Biochemistry, Analytical chemistry, or related sciences with a minimum of 1+ years (Ph.D.) or 5+ years (M.S.) of relevant and progressive experience in a Biotech setting.
• Significant experience and track record of successfully developing, qualifying, executing assays for characterization of mRNA and mRNA-LNP formulations using biophysical methods such as U/HPLC, LC-MS, capillary electrophoresis, UV-Vis, DLS, Zeta potential, etc.
• Understanding and experience in other mRNA analytics like Ribogreen, gel electrophoresis, or sequencing techniques, etc. is highly desirable.
• Experience in tech transfer activities to QC or external labs, plus working with partners, vendors, or clients is preferred.
• Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate requirement for product development is required.
• Prior experience of regulatory filings is preferred. Must have strong writing, and communication skills.
• Organization skills, and prior experience of mentoring scientists and associates is required.
• Experience of working with ELN and LIMS is preferred.