Senior/Scientist, Analytical CMC Drug Product, Process and Analytical Development

Translate Bio

Massachusetts, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 05/24/2021
  • Website:
  • Company Address: 790 Memorial Drive Suite 203, Cambridge, MA, 02139

About Translate Bio

Translate Bio is focused on pioneering the translation of RNA science into therapeutics promoting healthy gene expression in people living with debilitating genetic diseases. The company’s RNA platforms for powering endogenous therapeutic protein production is applicable to a broad range of diseases caused by insufficient protein production, including rare diseases of the liver, lung and central nervous system (CNS).

Job Description

Company Overview

Translate Bio is a leading mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. Our MRT platform is designed to deliver mRNA carrying instructions to produce proteins for therapeutic benefit and may potentially be applicable to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease. Our two lead programs are being developed as treatments for COVID19, Flu, and cystic fibrosis. We anticipate initiating a human clinical trial in patients with COVID19 and influenza in 2021.

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 a Scientist Analytical Development, CMC. The successful candidate will report to an 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 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 helps develop/optimize new assays.
    Work with project team members to support release of drug substance and drug product batches.
    Initiate and manage/coordinate stability studies and coordinate sample storage with vendor.
    Participate in method transfer activities to QC group, 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.

Required Skills & Qualifications

    B.S/MS in Chemistry with 10+ experience or PhD with 5-8 years relevant experience.
    Demonstrated success and analytical development knowledge/experience for drug products and drug substances
    Hands-on experience in multiple analytical techniques.
    Experience in analytical development is required, preferably within a pharmaceutical company setting or a CRO.
    Desire to work in a fast-paced environment
    Excellent organizational, multi-tasking, and communication skills
    Ability to manage vendors, transfer methods to CTL, and troubleshoot assay implementation at offsite labs.
    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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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.