СШАScientist I/Senior Engineer I, Pilot Lab Lead
1 нед. назад
СШАLead
rnalipid nanoparticleschromatographytangential flow filtrationproduction scheduling
Lead pilot lab operations producing engineered RNA and lipid nanoparticles, managing team and processes.
Обязанности
- Plan, execute, and deliver recurring gram-scale eRNA and tLNP manufacturing campaigns for large in vivo studies.
- Lead and participate in eRNA and/or tLNP manufacturing activities, including IVT, chromatography, T-mixer lipid formulation, conjugation or targeting operations, normal (NFF) and tangential flow filtration (TFF), and fill-finish, as applicable.
- Manage, coach, and develop a small team of scientists and/or engineers by setting priorities, assigning work, providing technical guidance, and supporting professional development.
- Oversee daily pilot laboratory operations, including production scheduling, capacity planning, equipment coordination, material readiness, inventory, and laboratory organization.
- Develop, implement, optimize, and transfer scalable eRNA and tLNP processes into routine pilot-laboratory manufacturing.
- Provide technical leadership for upstream and downstream eRNA production, including synthesis, purification, filtration, concentration, and buffer exchange.
- Troubleshoot complex process, equipment, and manufacturing issues using scientific or engineering principles and independent judgment.
- Identify bottlenecks and implement improvements that increase throughput, process robustness, consistency, and ease of execution.
- Author and review protocols, batch records, SOPs, technical reports, equipment procedures, and process-development documentation, ensuring records are accurate, complete, and traceable.
- Analyze process and analytical data, communicate recommendations, and collaborate with Process Development, Analytical Development, Research, Quality, Operations, Facilities, EHS, and in vivo study teams.
- Promote a culture of safety, accountability, collaboration, technical rigor, and attention to detail.
Требования
- Demonstrated experience leading, supervising, or developing technical personnel.
- Experience in biotechnology, pharmaceutical development, bioprocessing, or biologics manufacturing.
- Hands-on experience executing pilot-scale or gram-scale manufacturing processes.
- Experience developing, scaling, transferring, or routinely executing biological production processes.
- Experience with relevant unit operations such as TFF, chromatography, filtration, concentration, or buffer exchange.
- Strong technical writing, documentation, organizational, and problem-solving skills.
- Demonstrated ability to manage competing priorities and deliver manufacturing campaigns on schedule.
Будет плюсом
- Direct experience producing LNPs or tLNPs at gram scale for in vivo studies.
- Experience with RNA or eRNA synthesis, purification, and drug-substance manufacturing.
- Hands-on experience with T-mixer formulation and TFF process development or execution.
- Experience operating in a pilot-scale, process-development, GLP, or GMP-adjacent environment.
- Experience introducing new equipment or processes into an active manufacturing laboratory.
Другое
- The Scientist I/Senior Engineer I, Pilot Lab lead will oversee a pilot laboratory responsible for producing engineered RNA ( eRNA ) and targeted lipid nanoparticles ( tLNPs ). A primary responsibility is the regular execution and delivery of gram -scale eRNA and/or tLNP manufacturing campaigns. This individual will manage direct reports while remaining actively involved in laboratory operations. They will create an organized, efficient, and scalable working environment; introduce and improve processes; and ensure that manufacturing activities are completed safely, consistently, on schedule, and with accurate documentation. The role requires independent judgment, strong scientific or engineering acumen, and effective cross-functional collaboration.
- PhD in a relevant scientific or engineering discipline; MS with at least 6 years of relevant industry experience; or BS with at least 8 years of relevant industry experience.
- Master’s degree in engineering or a related discipline with at least 4 years of relevant industry experience; or BS in an engineering discipline with at least 6 years of relevant industry experience.