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 Technical Writer is responsible for working with the QC team at our BaseCamp facility in Waltham. This position will work with Quality management to author and review documents in support of ElevateBio’s programs as well as routine QC operations. The primary focus will be tracking, writing, and reviewing quality events. The Technical Writer will be expected to use their expertise to work independently to move quality records forward and ensure on-time closure.
Here’s What You’ll Do:
- Draft and review quality events, including deviations, lab investigations, and CAPAs.
- Draft, edit, and/or review SOPs, as needed, to close out quality events.
- Track open quality events and work with SMEs/management to ensure on-time closure.
- Assist with data review, as needed.
Requirements:
- B.S. or M.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 3 years of experience in GMP QC laboratory setting, preferably in a cell and gene therapy manufacturing environment.
- Experience with cell and gene therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, cell-based assays, sterility, environmental monitoring) is preferred.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Proficient at writing concise and thorough deviations and lab investigations.
- Ability to communicate and work independently with scientific/technical personnel.
- Excellent organizational skills.
- Experience performing laboratory investigations.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP).
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.
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.
