QC Associate II, 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 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:

• Bachelor’s degree in a technical discipline (Biology/Molecular Biology/Chemistry/Engineering) with a minimum of 1-5 years of experience, preferably in a GMP QC laboratory setting.
• Experience with the validation process for QC instruments.
• Excellent organizational skills and attention to detail.
• Ability to work independently and communicate/collaborate with scientific/technical personnel.
• Experience performing investigations for deviations.
• Knowledge of GMPs, SOPs, and Quality System processes.  
• Experience working with electronic systems (Kneat, CMMS, LIMS, QMS) 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.