Job Title: Scientist, 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./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.