QC Specialist I, QC Analytics Cell Therapy

4 weeks ago

Waltham, United States ElevateBio Full time

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 Specialist I will support product release testing within the QC analytical laboratory at our basecamp facility in Waltham. In this role, you will be responsible for qualifying, writing/reviewing protocols for, and executing cell and molecular biology assays for elevatebio's gene and cell therapy programs. Additionally, the QC Specialist I will investigate and review excursions and deviations generated during qualification and testing.
Here's What You'll Do:

Work cross-functionally with QC and Analytical Development to qualify and transfer developed assays.
Draft and review qualification/validation methods as well as associated test methods/SOPs and reports.
Perform routine analytical tests, analyze results, and record data/report in LIMS.
Collaborate with other QC functions to ensure all testing is completed within established timelines.
Investigate and review analytical testing excursions, including deviations, CAPAs and OOSs.
Assist in the training of laboratory staff.
Assist with QC-related batch disposition activities.

Requirements:

Bachelor's, or Master's, degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with a minimum of 5 years of experience, or 3 years with Master's degree. Experience in a GMP QC laboratory setting is preferred.
Significant experience with cell and gene therapy test methodologies (PCR, Flow Cytometry, ELISA, and cell-based assays). Significant experience with flow cytometry is highly preferred.
Experience drafting test methods and associated qualifications/validations.
Experience performing laboratory investigations.
Ability to work independently and communicate/collaborate with scientific/technical personnel.
Excellent organizational skills and attention to detail.
Significant knowledge of GMPs, SOPs, and Quality System processes.
Experience in cell and gene therapy manufacturing environment is a plus.
Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
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.

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