Sr. Engineer, GMP Process Development

Translate Bio

Sr. Engineer, GMP Process Development

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
The Sr. Engineer is an integral part of CPD&P team. This position offers leadership opportunities to focus on drug substance and drug product process development, manufacturing, regulatory and analytical support, validation, and data review for drug substances and drug products.  The Sr. Engineer is responsible for leading the development and execution of scalable and robust processes for drug substance and drug product and help serve as the CPD&P Subject Matter Expert (SME) for process knowledge transfer for drug substance and drug product to support cGMP manufacturing.
Job Responsibilities
  • Lead the project activities for the design and technology transfer of mRNA and nanoparticle manufacturing processes including authoring and reviewing of Batch Records/Master Production Records and SOPs. 
  • Represent the team as an SME on development and manufacturing related operations for drug substance and drug product.
  • Troubleshoot process/analytical issues that occur during scale-ups and/or in production of drug substance and drug product. 
  • Provide technical support for scale-up and manufacturing issues, and develop solutions to improve process efficiency and product quality
  • Effectively communicate with cross-functional teams like Analytical Development, R&D, Process Development, Project Management, Regulatory Affairs and Legal teams. 
  • Prepare technical reports and presentations that support scale-up activities and process improvements
  • Support and contribute to IND filings/regulatory documentation. 
  • Supervise/train associates and manufacturing technicians.
Required Skills & Qualifications
  • A Bachelor’s degree and/or Master’s degree in Chemical engineering or related field with 8+ years of relevant experience is required, Master’s preferred.
  • Demonstrated experience in process development/scale-up of drug substance or drug product is required.
  • A familiarity and hands-on experience with the development of novel drug carriers using nanoparticle formulations is required.
  • Experience with analytical tools for release and characterization of drug product processes and drug products is required.
  • Must have experience working within a GMP pharmaceutical manufacturing unit operations, such as lyophilization, filtration and fill/finish.  
  • Familiarity with cGMP, ICH and regulatory guidelines.
  • Demonstrated ability to apply fundamental scientific and engineering skills to evaluation of processes and development of practical solutions to technical challenges is required.
  • Ability to partner with CROs/CMOs .
  • 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.