QC Associate I, Analytics - Cell Therapy (Contract)

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.

The Role:

The QC Associate I will support method qualification and transfer testing activities, in-process and product release testing within the QC analytical laboratories at our basecamp facility in Waltham. In this role, you will independently perform analytical testing including but not limited to protein assays and/or cell and molecular biology assays for ElevateBio’s programs. The QC Associate I will help support routine laboratory maintenance, cleaning, and inventory.

Here’s What You’ll Do:

• Perform routine analytical tests, analyze results, and record data/report in LIMS.
• Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
• Work cross-functionally with Analytical Development to qualify and transfer developed assays.
• Collaborate with other QC functions to ensure all testing is completed and reviewed within established timelines.
• Draft test methods/SOPs.

Requirements:

• Bachelor’s, or Master’s, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with at least 1 years of related experience (may be <1 year for Master’s degree). Experience in a GMP QC laboratory setting is preferred.
• Experience in the following methodologies: qPCR/ddPCR, immunoassays, cell-based assays including Flow Cytometry, ELISpot, HPLC, AUC, and cIEF.
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate/collaborate with scientific/technical personnel.
• Knowledge of GMPs, SOPs, and Quality System processes.  
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

 

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.

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.