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 Director, Analytical Development reporting to the Head of Analytics to lead the development, qualification, and lifecycle management of novel assays for the characterization and testing of cell and gene therapy products and critical components. This is a highly visible position that will lead a team of scientists and will work cross-functionally with Quality, Regulatory, Process development, and Manufacturing teams of ElevateBio, as well as external partners.
Here’s What You’ll Do:
- Lead the development, optimization, and qualification of robust cell-based and biochemical assays for the characterization of cell and gene therapy drug products, vector, and other critical components.
- Provide expertise for enhancing existing assays, and implementation of new ideas and technologies.
- Provide leadership and guidance in designing and execution of method qualifications per ICH and regulatory guidelines.
- Represent the Analytical development team in cross-functional CMC meetings, and actively participate in strategy design, execution, data presentation and follow-up.
- Form active collaborations with teams within Analytical Development, and other functions, like Process development, Manufacturing, Quality, Regulatory, and Research.
- Collaborate with external partners, clients to lead/ monitor development activities, and ensure deliverables in a timely manner.
- Author technical reports, protocols, and relevant sections of regulatory filings.
- M.S. or Ph.D. in molecular biology, or related sciences with a minimum of 8 years (Ph.D.) or 12 years (M.S.) of relevant and progressive experience in a Biotech setting.
- Significant experience and track record of successfully developing cell-based and biochemical methods including complex potency bioassays, and residual impurity assays.
- Expertise in techniques like multicolor flow cytometry, ELISA, HPLC, etc.
- Extensive knowledge and strong scientific background related to CGT products and viral vectors (e.g., Lentivirus, AAV) 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.
- Experience in tech transfer activities to QC or external labs, plus working with partners, vendors, or clients is required.
- Prior experience of regulatory filings is strongly preferred. Must have strong writing, and communication skills.
- Organization skills, and prior experience of mentoring scientists and associates is required.
- Experience of working with LIMS is preferred.
- Experience working with automation of analytics is preferred.
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.