Job Title: Scientist, Formulation Process Development
Job Number: 23221
Location: Lexington, MA
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 Director of the group and will focus on process development for drug products.
- 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
- M.S./Ph.D. in Chemistry/Physical Chemistry/Chemical Engineering/Biochemistry
- M.S. with 8-10 years or Ph.D. with 2-4 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.
- Experience with lipid nanoparticles (LNP) is required
- Direct experience with messenger RNA encapsulation/quantification/characterization/handling is strongly preferred
- Demonstrated success in development of formulation processes & characterization of drug products.
- Experience handling nucleic acids 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.