We are seeking a highly motivated and scientifically rigorous individual to join the Research and Process Development team as a Scientist. The position will report to the Associate Director of the group and will focus on process development for drug products.

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

Qualifications

  • M.S./PhD in Chemistry/Physical Chemistry/Chemical Engineering/Biochemistry
  • 0 – 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.
  • Demonstrated success in development of formulation processes & characterization of drug products.
  • Direct experience with messenger RNA encapsulation/quantification/characterization/handling is 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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