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 looking for a highly motivated and scientifically rigorous individual to join the Drug Product Process Development team as a Sr. Engineer. The position will report to the Director and will focus on optimization and scale-up of LNP formulations in support of all programs at Translate Bio with the ultimate goal of transferring at scale methods to either the internal Pharmaceutical Sciences manufacturing team External Manufacturing team for GMP manufacturing of bulk and final DP.

Job Responsibilities
  • Scale-up and optimization of bulk DP formulation and final DP processes encompassing a wide range of DS and multi-component LNPs
  • Communicate with Formulation Development group to tech transfer new formulations into Process Development
  • Design and execute experiments with limited input from supervisor and team while incorporating QbD principles to further process understanding
  • Keep detailed records using an electronic laboratory notebook
  • Present experimental results to group and CMC teams as needed
  • Critical thinking and analysis of data will be central to all aspects of this position
  • Design, procure, and maintain equipment in the Process Development lab and pilot plant
  • Produce materials that is representative of cGMP material and suitable for nonclinical studies including GLP toxicology studies
  • Prepare technical reports and presentations to clearly communicate scientific findings
  • Support tech transfer from Process Development to internal and external manufacturing groups, which includes drafting development batch records
  • May provide mentoring to junior staff
Required Skills & Qualifications
  • BS/MS in Chemical Engineering or in a related field with at least 8 years of relevant experience
  • Candidate with process development experience is required
  • Strong working knowledge of TFF including optimization and scaling is highly desirable
  • Experience with LNP formulations of mRNA is desirable
  • Working knowledge of quality systems, GMP, and regulatory guidelines is desirable
  • Capable of working in a collaborative team environment both within group and on interdisciplinary teams
  • Desire to work in a fast-paced environment
  • Excellent organizational and communication skills
  • Strong analytical and problem-solving skills
  • Ability to present findings to a diverse scientific group in a clear and concise manner is necessary
  • Ability to travel (U.S./ International) 10-20% of time.
Translate Bio is committed to equal employment opportunity. All applicants must have authorization to work in the U.S.
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