Quality Control Specialist for Cell and Gene Therapy

6 days ago

Waltham, Massachusetts, United States ElevateBio Full time

ElevateBio is a pioneering technology-driven company dedicated to accelerating the development of cutting-edge genetic medicines. With a comprehensive model that integrates multiple technologies, we offer turnkey scale and biotechnological capabilities to power genetic medicine processes, programs, and companies.

The Role

In this key position, you will support in-process and product release testing within the Quality Control analytical laboratories at our Waltham facility. Your primary responsibilities will include qualifying, writing/reviewing method protocols, and executing assays related to protein and/or cell and molecular biology. You will work closely with cross-functional teams to ensure timely completion of testing and collaborate with other Quality Control functions to guarantee seamless execution.

  • Work collaboratively with Quality Control Analytical Development to qualify and transfer developed assays.
  • Draft and review qualification/validation methods, associated test methods/SOPs, and reports.
  • Perform routine analytical tests, analyze results, and record data/report in Laboratory Information Management Systems (LIMS).
  • Collaborate with other Quality Control functions to ensure all testing is completed within established timelines.
  • Investigate and review analytical testing excursions, including deviations, Corrective Action Preventative Actions (CAPAs), and Out-of-Specification (OOS) results.

Requirements:

  • Bachelor's or Master's degree in a technical discipline (Biology/Chemistry/Microbiology or related field) with at least 3 years of related experience (1 year for Master's degree).
  • Significant experience in methodologies such as quantitative Polymerase Chain Reaction (qPCR)/digital droplet PCR (ddPCR), immunoassays, cell-based assays including Flow Cytometry, High-Performance Liquid Chromatography (HPLC), Analytical Ultracentrifugation (AUC), and Capillary Isoelectric Focusing (cIEF).
  • Experience drafting test methods and associated qualifications/validations.
  • Excellent organizational skills and attention to detail.
  • Ability to work independently and communicate/collaborate with scientific/technical personnel.
  • Significant knowledge of Good Manufacturing Practices (GMPs), Standard Operating Procedures (SOPs), and Quality System processes; experience in a GMP Quality Control laboratory setting is preferred.
  • Experience working in cell and gene therapy manufacturing environments is a plus.
  • Experience working with electronic systems (LIMS, Computerized Maintenance Management Systems (CMMS), Quality Management Systems (QMS), Enterprise Resource Planning (ERP)) is a plus.

We estimate the annual salary for this position to be around $80,000-$110,000 based on industry standards and location factors.

ElevateBio is an equal opportunity employer committed to diversity and inclusion. We are dedicated to creating a workplace where everyone feels valued, respected, and empowered to contribute their best work. Our goal is to become the leading provider of innovative solutions in the cell and gene therapy space.

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