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2 weeks ago
We are seeking a skilled Process Development Scientist to join our team in a hands-on, cross-functional role that blends scientific expertise with operational excellence.
Key Responsibilities:- Design and optimize LNP manufacturing processes by applying Quality by Design (QbD) principles and execute Design of Experiments (DoEs) to identify and control critical process parameters (CPPs)
- Optimize analytical methods such as DLS, Ribogreen, HPLC-CAD, IP-RP-HPLC, and endotoxin to identify and access critical quality attributes (CQAs)
- Interpret analytical data to assess process robustness and guide iterative development efforts
- Collaborate with internal teams to support process improvements and drive innovation
- Clearly present scientific findings and project updates in internal meetings and to external collaborators
- Drive technology transfer activities with external CDMO partners by preparing comprehensive technical documentation such as development reports, process summaries, and tech transfer packages to ensure successful external manufacturing
- Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with minimum of 3 years relevant industry experience; or M.S. with 6 years; or B.S. with 8 years
- Demonstrated expertise in LNP formulation and process development, including hands-on experience with microfluidic and high-shear mixing technologies, tangential flow filtration and dead-end filtration
- Proficiency in analytical characterization techniques for LNPs, including DLS, fluorescence-based assays and HPLC/UPLC methods (CAD, UV, IP-RP, SEC, IEX), including method development, troubleshooting, and data interpretation
- Experience with in-process and drug product stability studies
- Proven success in applying DoEs and statistical analysis tools for process optimization
- Experience supporting technology transfer of processes to external manufacturing environments, with a strong understanding of tech transfer best practices
- Demonstrated strong organizational skills
- A self-starter with demonstrated strong troubleshooting skills, capable of driving projects independently while contributing effectively in a collaborative, multidisciplinary environment
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