ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.
The Role:
The QC Associate will support GMP testing in QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for performing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.
Here’s What You’ll Do:
- Perform routine testing using established test methods, analyze the results, and record/report the data.
- Perform peer-review of data records and testing reports.
- Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
- Collaborate with other QC functions to ensure all testing is completed within established timelines.
- Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
- Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
- Assist in drafting and/or editing procedures for testing and/or equipment.
Requirements:
- Bachelor’s, or Master’s, degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field). 1-5 years of experience with a Bachelor’s, 1-3 years with a Master’s.
- Experience working in a GMP setting preferred.
- Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
- Excellent organizational skills and attention to detail.
- Ability to work independently as well as communicate and collaborate with scientific/technical personnel.
- Experience performing laboratory investigations.
- Knowledge of GMP, SOPs, and Quality System processes.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
* Multiple positions available at Associate I, Associate II level.
* Contract length is 9 months.
The budgeted range for this position is $33/hour - $48/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.
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.
Skills Required
- Bachelor's or Master's degree in Biology, Molecular Biology, Biochemistry, Chemistry or related field (with 1-5 years experience for Bachelors, 1-3 years for Masters)
- Experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, cell culture, cell-based assays)
- Experience performing laboratory investigations (deviations, CAPAs, OOS)
- Knowledge of GMP, SOPs, and Quality System processes
- Excellent organizational skills and attention to detail
- Ability to work independently and collaborate with scientific/technical personnel
- Experience working in a GMP setting
- Experience with electronic systems (LIMS, CMMS, QMS, ERP)
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.
