Company Overview
We are a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Using our proprietary mRNA therapeutic platform (MRT), we create mRNA that encodes functional proteins. Our mRNA is delivered to the target cell where the cell’s own machinery recognizes it and translates it, restoring or augmenting protein function to treat or prevent disease.

At Translate Bio, we’re also passionate about our five core values: Put People First, Be Approachable, Act as One, Be Tenacious, and Be Bold. These values embody our culture and underscore our mission to bring mRNA therapeutics to all.

Job Summary
The Quality Control Analyst is primarily responsible for reviewing testing at Translate Bio and applicable contract testing labs for mRNA drug substance, LNP drug product, and critical raw materials. This person is responsible for ensuring all test analyses are performed according to SOPs and results are accurately reported by contract labs. In addition, this person will assist with setting up an in-house Quality Control lab.
 
Analytical method support will include tracking and trending stability test data, monitoring of analytical standards and controls performance, data integrity reviews, and authoring and/or review of stability reports. The candidate will also help support Translate Bio’s efforts to internalize testing for drug substance, drug product, and critical raw material assays.

Job Responsibilities
  • Review and analysis of GxP raw data from various contract laboratories
  • Interact with CTL personnel to resolve any discrepancies or findings within reported data packets.
  • Issue Certificates of Analysis and Testing
  • Manage stability data and issue interim and final stability reports
  • Track and trend analytical data
  • Assist and advise Director on development of in-house QC laboratory
  • Assume additional responsibilities as assigned.
Required Skills & Qualifications
  • 2-4 years’ experience in Quality Control labs, including experience working with contract vendors.
  • B.S. in Chemistry or related scientific field
  • Working knowledge of Pharmaceutical/Biotech analytical methods within environment
  • Experience with and knowledge of analytical equipment and techniques.
  • Proven ability to operate successfully as part of a team in achieving short and long-term goals.
 Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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