QC Specialist II, Viral Vector Details

QC Specialist II, Viral Vector

ElevateBio - Waltham, MA

Employment Type : Full-Time

ElevateBio is a cell and gene therapy technology company built to power the development of 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 Role:

The QC Specialist II will support viral vector product release testing within the QC Viral Vector laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for analytical testing (cell and molecular biology assays, protein assays) and excursion/deviation investigations and reports in support of ElevateBio's viral vector programs. Additionally, the QC Specialist II will assist in qualifying, writing, and reviewing protocols for these assays.

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 within established timelines.
• Draft and review qualification/validation methods, associated test methods/SOPs, and reports.
• Assist in the training of laboratory staff.

Requirements:

• Bachelor's or Master's degree in a technical discipline (Biology/Molecular Biology/Chemistry/Biochemistry or related field) with a minimum of 4 years of experience, or 2 years with Master's degree, preferably in a GMP QC laboratory setting.
• Experience with LVV and AAV test methodologies (qPCR/ddPCR, immunoassays, cell-based assays including Flow Cytometry, HPLC, AUC, and cIEF).
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate/collaborate with scientific/technical personnel.
• Experience performing laboratory investigations.
• 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 the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

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.