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:
The Associate II of the Analytical Testing Core is responsible for performing non-GMP assays in support of the research, development, and manufacturing functions at our Basecamp facility in Waltham. This position will work with Analytical Development to transfer pre-qualified assay into the Analytical Testing Core for routine use. Once transferred, the associate will receive, prepare, and test samples per the established test method. Upon testing completion, the associate will ensure the timely review and reporting of data to the submitting group.
Here’s What You’ll Do:
- Work with management to implement laboratory systems to manage sample receipt, test execution, data integrity, and reporting.
- Draft SOPs, forms, and test records for the methods and equipment used in the Analytical Testing Core
- Implement test methods developed and pre-qualified in Analytical Development for routine non-GMP testing.
- Perform daily laboratory operations, including routine testing, inventory management, reagent ordering, and maintenance activities.
- Communicate with management and cross-functional stakeholders to ensure all testing is initiated and completed within required project timelines.
- Maintain control charts to monitor the performance of methods within Analytical Testing Core laboratory.
Requirements:
- Bachelor's degree with 1-3 years of experience in a technical discipline (Biology/ Chemistry/ Microbiology or related field).
- Experience working in an Analytical Development or Quality Control
- Experience with gene and cell therapy test methodologies (cell culture, Flow Cytometry, ELISA, ddPCR, and cell-based assays)
- Preferred: experience with biochemical and biophysical test methodologies like ELISA, U/HPLC, CE-SDS, etc.
- Ability to work in a collaborative team environment to meet project goals and testing turnaround times.
- Strong communication skills with an ability to clearly present complex scientific concepts and data.
- Experience in cell and gene therapy manufacturing environment is a plus.
- Experience working with electronic systems (LIMS and ELN) is a plus.
- This is a full-time on-site lab-based role. May require evening and weekend work to support business goals.
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.
Top Skills
What We Do
ElevateBio is a technology driven company powering transformative cell and gene therapies today and for many decades to come.
The company has assembled industry-leading talent, built world-class facilities, and integrated diverse technology platforms necessary for rapid innovation and commercialization of cell, gene, and regenerative therapies. The company has built an initial technology stack, including gene editing, induced pluripotent stem cells, and protein, viral, and cellular engineering. At the center of the business model is ElevateBio BaseCamp, a centralized R&D and manufacturing company that offers research and development (R&D), process development (PD), and Current Good Manufacturing Practice (CGMP) manufacturing capabilities. The company is focused on increasing long-term collaborations with industry partners while also continuing to develop its own highly innovative cell and gene therapies. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass.
