ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power cell and gene therapy processes, programs, and companies to their full potential.
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.
- 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.
Why Join ElevateBio?
ElevateBio is accelerating access to the cutting-edge technologies and expertise that will change the future of medicine. Our ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene-editing platform; a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, our end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.
With these leading-edge platforms and capabilities, we are enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies while also building our own innovative pipeline of cellular, genetic, and regenerative medicines. Together, we aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.