Principal Associate Scientist, Analytical Development (Contractor)
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 genetic medicines processes, programs, and companies to their full potential.
The Role:
ElevateBio 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 of Elevatebio. This is a four-month contract role.
Here’s What You’ll Do:
- Execute and support the development, optimization and execution of molecular assays in close collaboration with the Elevatebio 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.
Why Join ElevateBio?
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
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.