Scientist, Lyophilization Formulation

Translate Bio

Lexington, MA, US
  • Job Type: Full-Time
  • Function: Research Sci/Assoc/Mgr
  • Post Date: 12/30/2020
  • Website: translate.bio
  • 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

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. 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.

Job Summary

We are seeking a highly motivated and scientifically rigorous individual to join the Research and Process Development team as a Lyophilization Formulation Scientist. The position will report to the Director of Delivery & Formulations group and will focus on developing lyophilized formulations and executing unique methods required for mRNA formulation characterization and stability testing.

Job Responsibilities

    Lead the development of lyophilization for mRNA formulations including, but not limited to, lipid nanoparticle technologies. Develop lyophilization cycles & processes to increase stability of mRNA drug products. Focus on new product development & current product improvement
    Identify, design, execute, and evaluate mRNA formulations through stability studies and develop robust lyophilized formulations showing improved stability in refrigerated conditions.
    Perform analytical assays as needed to assess stability and integrity of drug product formulations.
    Lead the formulation and product development and stability assessment activities that may include pre-formulation activities, buffer/excipient screening and selection, developing lyophilized or freeze stable formulations.
    Focus on stability testing and characterization of routes of degradation of mRNA formulations in liquid and lyophilized formulations under accelerated temperature, refrigerated storage conditions and under different stresses in a variety of containers.
    Work closely and build relationships with CROs / CMOs with focus on developing lyophilized formulations
    Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams

Required Skills & Qualifications

    PhD in Chemistry/Physical Chemistry/Chemical Engineering/Pharmaceutical Sciences
    2 - 6 years of experience in lyophilization development and stability testing
    Hands-on experience and deep understanding of lyophilization process development and lyophilized products in different packaging systems. Cycle design, excipient selection and buffer screening expertise is required. Prior experience in developing lyophilized nanoparticle formulation is preferred.
    Extensive experience in stability studies and analytical assays for stability evaluation
    Working knowledge in Design of Experiments, QbD and statistical principles
    Works collaboratively within group as well as within interdisciplinary teams
    Demonstrated successful 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.