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Process Development Senior Research Associate/Engineer
2 months ago
The Position
As an Engineer I or Senior Research Associate in the LNP Process Development team, the candidate will be joining a team conducting laboratory studies to support the process development, process scale-up, and manufacturing of company LNP drug product. This candidate will have experience with lipid nanoparticle process development (having additional experience in tech transfer and GMP manufacturing is a plus but not required), and a desire to contribute to a team focused on establishing science-based manufacturing solutions for complex nucleic acid-based drug products. This is an on-site, lab-based role.
Responsibilities
- Plan and execute experiments at bench scale to support process development and optimization of company LNP drug product manufacturing process to assist in establishing a science-based understanding of LNP process development
- Willingness to collaborate with cross-functional analytical development, tech transfer, and external manufacturing functional teams
- Ability to achieve results, keep to timeline, and find solutions to ensure that overall project deliverables are met.
- Perform experiments under limited to no supervision under subject matter expert guidance
- Organize and analyze data, interpret results, record experiments in an electronic lab notebook, and summarize work in presentations and technical reports
- Actively engage in all aspects of laboratory activities, and troubleshooting of both internal and external manufacturing processes
Qualification and Skills
- Bachelor’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 3+ years of relevant industry experience or Master’s degree in chemical/ biomedical engineering, chemistry, or biological sciences with 0 + years of relevant industry experience
- Knowledge with bench-scale drug product manufacturing of LNPs (required), biologics, or nucleic acids, with a focus on mixing and TFF processes.
- Experience with practices and equipment used in process development of nucleic acids; T-mixing and TFF is strongly preferred
- Attention to detail, analysis of data/reports, troubleshooting and problem-solving abilities.
- Ability to perform in-process analytical methods including dynamic light scattering, osmolality, pH, and fluorescence assays. Additional are a plus.
- Writing and communication skills; ability to understand and communicate scientific information
- Experience with technical documentation (SOPs, technical reports, protocols) is a plus
- Knowledge of practices of GMP manufacturing, and tech transfer operations is a plus
