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QC Associate I

1 month ago

Waltham MA United States Vertex Ventures HC Full time

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to 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 GMP testing in QC laboratories at our BaseCamp facility in Waltham. In this role, you will be responsible for performing cell and molecular biology assays, as well as basic laboratory maintenance in support of ElevateBio’s gene and cell therapy programs. Additionally, the QC Associate may assist in qualifying these assays.

Here’s What You’ll Do:

  1. Perform routine testing using established test methods, analyze the results, and record/report the data.
  2. Perform peer-review of data records and testing reports.
  3. Assist with investigating and reviewing testing excursions, including deviations, CAPAs and OOSs.
  4. Collaborate with other QC functions to ensure all testing is completed within established timelines.
  5. Share responsibility with peers to manage inventory and reagents, and perform maintenance and other daily lab operations.
  6. Work cross-functionally with Analytical Development and other QC functions to assist in the qualification of developed assays.
  7. Assist in drafting and/or editing procedures for testing and/or equipment.

Requirements:

  1. Bachelor’s or Master’s degree in a technical discipline (Biology/Molecular Biology/Biochemistry/Chemistry or related field).
  2. 1-5 years of experience with a Bachelor’s, 1-3 years with a Master’s.
  3. Experience working in a GMP setting preferred.
  4. Experience with cell and gene therapy test methodologies (i.e. PCR, Flow Cytometry, ELISA, cell culture, cell-based assays).
  5. Excellent organizational skills and attention to detail.
  6. Ability to work independently as well as communicate and collaborate with scientific/technical personnel.
  7. Experience performing laboratory investigations.
  8. Knowledge of GMP, SOPs, and Quality System processes.
  9. 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.

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.

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