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.
Key Responsibilities:
- 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.
Requirements for Either Level:
- 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.
Qualifications:
Scientist I
- 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.
Senior Engineer I
- 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.
Preferred Qualifications:
- 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.
Salary Range: $100,000 - $150,000
Sail Biomedicines is an Equal Opportunity Employer. Sail does not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.
