Senior Engineer, Process Development (Drug Product)

Translate Bio

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/26/2021
  • 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

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 the Research and Process Development team as a Senior Engineer, Process Development. The position will report to the Director of the group and will focus on process development for drug products.

Job Responsibilities

  • Design and conduct experiments for advancing understanding and further developing drug product formulations
  • Scale up and characterize drug product processes
  • Analyze, interpret the results and plan future experiments based on the findings which will advance efforts of process development
  • Write batch records/protocols for manufacture of drug product
  • Write/review analytical method protocols/stability protocols
  • Characterize biophysical and physiochemical properties of drug product formulations
  • Further expand delivery capabilities for Translate Bio and build our intellectual property estate
  • Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams

Required Skills & Qualifications

  • M.S./Ph.D. in Chemical Engineering/Biochemistry/Chemistry/Physical Chemistry
  • M.S. with 8-10 years or Ph.D. with 2-4 years of relevant experience in process development, tech transfer and working in manufacturing/production group.
  • Comprehensive know-how and direct experience of different pump systems, TFF, fluid flow and mixing dynamics in formulation processes is a must.
  • Experience with lipid nanoparticles (LNP) is required
  • Direct experience with messenger RNA encapsulation/quantification/characterization/handling is strongly preferred
  • Demonstrated success in development of formulation processes & characterization of drug products.
  • Experience handling nucleic acids preferred
  • Experience with biophysical characterization assays for delivery systems.
  • Working knowledge of Quality systems, GMP-related requirements, regulatory requirements for CMC and ICH guidelines is desirable
  • Strong disposition for analytics (QC, methods, assay development)
  • Works collaboratively within group as well as within interdisciplinary teams
  • Demonstrated experience in working with outside CROs/CMOs
  • Manages time effectively demonstrating ability to perform multiple projects at one time
  • 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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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.