QC Associate II, Equipment Management (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 genetic medicines processes, programs, and companies to their full potential.

The Role :

The QC Associate will support the QC laboratory at our BaseCamp facility in Waltham. In this role, you will be primarily responsible for managing the lifecycle of QC instruments used in support of ElevateBio's vector, gene and cell therapy programs.

Here's What You'll Do :

• Collaborate with all QC functions (i.e. QC Microbiology, QC Raw Materials, QC Analytics, and QC Outsourcing / Logistics) and Analytical Development to onboard QC instruments and ensure that validation is appropriate given the use of the system.
• As the QC system owner, collaborate with Validation Engineering, IT, Metrology, and QA Validation to author or review and approve IOQ / validation packages, including IA, URS, and associated validation plan / report.
• Draft and / or revise operational SOPs.
• Review OOTs identified following calibration and initiate deviations as appropriate.
• Oversee equipment / instrument maintenance, PM, and calibration, in collaboration with asset owner, facilities, and metrology.

Requirements :

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.