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 QC Specialist I to support QC analytical activities outsourced to contract testing laboratories as well as QC logistics at ElevateBio. This role will require the comprehension of assay protocols and review of data analysis and reports of executed testing. The QC Specialist I will support the review of investigation and deviation reports generated by the testing laboratories and may assist in the preparation of in-house reports associated with these events. This role will also require supporting the outsourced testing logistics such as sample submission documentation, scheduling shipments with supply chain, material pack out, and tracking samples once submitted. The QC associate will support QC sample management, such as labeling and receipt, and inventory management within ElevateBio. The role will also require management of stability programs from writing stability protocols to trending stability data and completing final reports. The QC Specialist I position on the QC Logistics team will report directly to the manager of QC Logistics.
Here’s What You’ll Do:
- Review/analyze testing protocols generated by contract testing laboratories for cell and gene therapy production lots including engineering and clinical material.
- Analyze incoming data and transfer information into internal systems (e.g. LIMS and QMS).
- Review deviations/investigations from outsourced laboratories.
- Authoring and reviewing quality events.
- Manage logistics of shipping activities between contract manufacturing organization, investigators, and contract testing laboratories for both routine testing and investigational work.
- Handle internal QC sample submission process which includes labeling, sample receipt, and sample inventory.
- Writing stability protocols and managing stability testing and data review.
Requirements:
- Bachelor’s degree in technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with a minimum of 3-5 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Knowledge of typical gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA/ELISpot, HPLC and cell-based assays).
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMP, SOPs, and quality system processes.
- Excellent organizational skills.
- Experience in cell and gene therapy manufacturing environment is a plus
- Experience performing laboratory investigations
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.
