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Job Title: Lyophilization formulation Scientist/ Senior Scientist

Job Number: 23217

Location: Lexington, MA 02421

Job Description

We are seeking a highly motivated and scientifically rigorous individual to join the Research and Process Development team as a Lyophilization formulation Scientist/ Senior 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.

Responsibilities

  1. 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
  2. Identify, design, execute, and evaluate mRNA formulations through stability studies and develop robust lyophilized formulations showing improved stability in refrigerated conditions.
  3. Perform analytical assays as needed to assess stability and integrity of drug product formulations.
  4. 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.
  5. 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.
  6. Work closely and build relationships with CROs / CMOs with focus on developing lyophilized formulations
  7. Prepare technical reports and presentations for clear communication of scientific findings across interdisciplinary teams

Required Skills

  1. PhD in Chemistry/Physical Chemistry/Chemical Engineering/Pharmaceutical Sciences 
  2. 2 – 6 years of experience in lyophilization development and stability testing
  3. 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.
  4. Extensive experience in stability studies and analytical assays for stability evaluation
  5. Working knowledge in Design of Experiments, QbD and statistical principles
  6. Works collaboratively within group as well as within interdisciplinary teams
  7. Demonstrated successful experience in working with outside CROs/CMOs
  8. Manages time effectively demonstrating ability to perform multiple projects at one time
  9. Desire to work in a fast-paced environment
  10. Excellent organizational and communication skills
  11. 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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