Beacon Hill
Process Development Senior Research Associate/Engineer
Beacon Hill, Boston, Massachusetts, us, 02108
The PositionAs 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.
ResponsibilitiesPlan 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 developmentWillingness to collaborate with cross-functional analytical development, tech transfer, and external manufacturing functional teamsAbility 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 guidanceOrganize and analyze data, interpret results, record experiments in an electronic lab notebook, and summarize work in presentations and technical reportsActively engage in all aspects of laboratory activities, and troubleshooting of both internal and external manufacturing processes
Qualification and SkillsBachelor’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 experienceKnowledge 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 preferredAttention 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 informationExperience with technical documentation (SOPs, technical reports, protocols) is a plusKnowledge of practices of GMP manufacturing, and tech transfer operations is a plus
ResponsibilitiesPlan 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 developmentWillingness to collaborate with cross-functional analytical development, tech transfer, and external manufacturing functional teamsAbility 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 guidanceOrganize and analyze data, interpret results, record experiments in an electronic lab notebook, and summarize work in presentations and technical reportsActively engage in all aspects of laboratory activities, and troubleshooting of both internal and external manufacturing processes
Qualification and SkillsBachelor’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 experienceKnowledge 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 preferredAttention 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 informationExperience with technical documentation (SOPs, technical reports, protocols) is a plusKnowledge of practices of GMP manufacturing, and tech transfer operations is a plus