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 Scientist is primarily responsible for overseeing all cGMP testing at Translate Bio and their contract testing labs for their mRNA drug substance, LNP drug product, and critical raw materials.  This includes analytical data review, deviations, investigations, method validations and transfers. This person is responsible for coordination of these activities with manufacturing and contract testing laboratories. In addition, this person will be responsible for assisting with setting up an in-house Quality Control lab.
 
Analytical method support will include but will not be limited to continuous monitoring of method performance, investigation/OOS management, data integrity reviews, and authoring and/or review of relevant sections of IND/IMPD and NDA/MAA and APQR (for example, IPC/raw materials testing and control, method validation, specifications, batch analysis, reference standard, and stability). The candidate will also help support Translate Bio’s efforts to internalize cGMP testing for drug substance, drug product, and critical raw material assays.

Job Responsibilities
  • Review and analysis of GxP raw data from various contract laboratories
  • Issue Certificates of Analysis and Testing
  • Manage stability data and issue interim and final stability reports
  • Track and trend analytical data 
  • Provide technical advice in investigations, deviations, and OOSs
  • Develop phase appropriate and risk-based quality control strategies and procedures to support clinical development.  Write SOPs as needed.
  • Recruitment training, performance management, and professional development of Quality Control Testing personnel
  • Ensure successful technical transfer, method validation and routine GMP, GLP, and GCLP testing in collaboration with Analytical Development and external QC test labs.
  • Provide technical advice to analytical scientists and associates to assure the highest quality of data is developed and presented
  • Guide method validations and transfers at contract labs
  • Assist and advise Director on development of in-house GMP QC laboratory
  • Assume additional responsibilities as assigned.  
Required Skills & Qualifications
  • 7-10 years experience in GMP Quality Control labs, including experience working with contract vendors.
  • MS/Ph.D. in Chemistry or related scientific field
  • Expert knowledge in Pharmaceutical/Biotech analytical methods under cGMP environment
  • Expert knowledge in Method validations and transfers, including regulatory requirements for US and ex-US clinical studies.
  • Expertise in troubleshooting analytical methods
  • Experience with a wide range of analytical equipment, ability to troubleshoot and maintain equipment.
  • Proven ability to operate successfully as part of a team in achieving short and long-term goals.
  • Knowledge and experience working with liposomes or lipid nanoparticles preferred but not necessary.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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