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
We are seeking a highly motivated and scientifically rigorous individual to join our team as an Associate Scientist Analytical Development, CMC. The successful candidate will report to the Associate Director, Analytical CMC and be an integral part of the CMC drug product team. This position offers opportunities to contribute to the analytical development function within CMC and overall CMC strategy of drug development at Translate Bio. The successful candidate will be responsible for the development, validation and transfer of analytical methodologies, release and stability testing for drug substance, drug product and raw materials, and general laboratory operations.

Job Responsibilities
  • Execute quality control activities as assigned by management, including analysis of raw materials, drug substance and drug product samples. Prepare and analyze samples according to established test methods or help develop new assays.
  • Work with project team members to support release of drug substance and drug product batches.
  • Initiate and manage/coordinate stability studies substance and drug product and coordinate sample storage with vendor.
  • Participate in method transfer activities, the maintenance and troubleshooting of laboratory equipment, and coordinate outsourcing of testing with vendors.
  • Assist in technical review of analytical development supporting documents including protocols, reports and methods.
  • Work with CMO’s/CRO’s on technology transfer of assays to support development and CMC.
  • Assist in the execution of analytical development experiments to improve platform analytics capabilities.
  • Provides mentoring, training and guidance to new team members.
Required Skills & Qualifications
  • Minimum B.S in Chemistry/biochemistry with 5 years’ relevant experience or MS with one year of relevant experience
  • Demonstrated success and analytical development knowledge/experience for raw materials, drug substances, and drug products in pharmaceuticals
  • Hands-on experience in multiple analytical techniques
  • Experience in analytical development is required, preferably within a pharmaceutical company setting or a CRO
  • Knowledge of cGMP compliance requirement is preferred
  • Proven ability to adhere to good documentation standard and maintain detailed record for all work performed
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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