Scientist I, Analytical Development

The Role:
ElevateBio is looking for a dedicated Scientist to join our Analytical Development-Molecular Biology Team. The ideal candidate will independently develop, optimize, and qualify molecular assays to evaluate cell and therapy products and critical components. This role will largely focus on molecular tools including Next-Generation Sequencing (NGS) and other sequencing-based assays, plus PCR-based techniques for the characterization of AAV products and the identification of on- and off- target effects in gene editing within cell and gene therapy space. A significant element of this position involves close collaboration with cross-functional teams including Quality, Regulatory, Process Development, and Manufacturing within ElevateBio, as well as external partners and CROs. Exceptional communication skills are essential to succeed in this role.

Here’s What You’ll Do:

• Develop, optimize, and qualify robust molecular and biochemical assays using techniques like ddPCR, qPCR, NGS based analytics for the characterization of cell and gene therapy drug products, vector, and other critical components.
• Design and execute experiments to characterize on- and off-target events of double-strand break (DSB) and non-DSB gene editing technologies.
• Coordinate with the computational biology team to assist with interpretation of NGS data to ensure quality, clarity, and accuracy of results.
• Pioneer and evaluate novel assay technologies and methodologies to enhance current analytical methods for cell and gene therapy products.
• Foster active collaborations with teams within Analytical Development, and other functional groups including Process development, Manufacturing, Quality, Regulatory, and Research.
• Initiate and manage collaborations with CROs, ensuring successful execution of join projects.
• Interface with external partners and clients to guide molecular biology assay development activities and ensure deliverables in a timely manner.
• Author technical reports, protocols, and relevant sections of regulatory filings.

Requirements:

• PhD. or M.S. in molecular biology, Virology, Bioanalytical Chemistry, or related field with 1-2 years (Ph.D.) or 4+ years (M.S.) of relevant experience in molecular applications including NGS technologies.
• Experience with design of experiment with sequencing platforms, i.e., Illumina, PacBio, NanoPore or others is highly preferred.
• Demonstrable strong experience with molecular assays, including:
• Proficiency in DNA/RNA isolation and NGS library construction.
• Hands-on experience with developing NGS data analysis tools and expertise in using analysis software for data analysis from Illumina, PacBio, NanoPore or others.
• Hands-on experience in qPCR/ddPCR methods and primer/probe design.
• Familiar with DNA/RNA sequence analysis tools, database software, and basic bioinformatics.
• Scientific background related to cell and gene therapy products, viral vectors (e.g., Lentivirus, AAV), and gene editing tools is needed.
• Prior hands-on experience with qualifying and validating assays; understanding of ICH/ FDA guidelines, and phase appropriate requirement for product development is required.
• Excellent oral, written, and verbal communication skills, coupled with the ability to thrive in a highly collaborative, fast-paced environment.