Job Overview
We are seeking a seasoned professional to fill the role of Senior Process Developer. This is an exciting opportunity for someone with expertise in LNP formulation and process development.
Key Responsibilities:
* Apply Quality by Design (QbD) principles to design and optimize LNP manufacturing processes, execute Design of Experiments (DoEs) to identify and control critical process parameters (CPPs)
* Develop analytical methods such as DLS, Ribogreen, HPLC-CAD, IP-RP-HPLC, and endotoxin to assess critical quality attributes (CQAs)
* Interpret analytical data to evaluate process robustness and drive iterative development efforts
* Collaborate with cross-functional teams to advance process improvements and innovation
* Present scientific findings and project updates effectively in internal meetings and to external partners
* Facilitate technology transfer activities with external CDMO partners by preparing comprehensive technical documentation to ensure successful external manufacturing
* Stay current with emerging trends in LNP technologies and contribute to strategic process enhancements
* Maintain accurate inventory records, plan experiments, and contribute to a well-organized lab environment
The ideal candidate will excel at the intersection of process development, analytics, and manufacturing, with the ability to transition seamlessly between laboratory work and interactions with external stakeholders. This is a great opportunity to play a key role in advancing cutting-edge gene editing therapies into clinical trials and beyond.
Requirements:
* Ph.D. in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, or a related field with minimum 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 organizational skills and ability to work independently in a collaborative environment