Sendabiosciences
Scientist I/Senior Engineer I, Pilot Lab Lead
Cambridge, MA. Posted a month ago
The role
The Scientist I/Senior Engineer I, Pilot Lab lead will oversee a pilot laboratory responsible for producing engineered RNA and targeted lipid nanoparticles. This person will manage direct reports and execute gram-scale manufacturing campaigns.
What you will do
- Plan, execute, and deliver recurring gram-scale eRNA and tLNP manufacturing campaigns.
- Lead and participate in manufacturing activities including IVT, chromatography, T-mixer lipid formulation, conjugation, filtration, and fill-finish.
- Manage, coach, and develop a small team of scientists and/or engineers.
- Oversee daily pilot laboratory operations including production scheduling, capacity planning, and inventory.
- Develop, implement, optimize, and transfer scalable eRNA and tLNP processes.
- Provide technical leadership for upstream and downstream eRNA production.
- Troubleshoot complex process, equipment, and manufacturing issues.
- Identify bottlenecks and implement improvements to increase throughput and robustness.
- Author and review protocols, batch records, SOPs, technical reports, and equipment procedures.
- Analyze process and analytical data and collaborate with cross-functional teams.
Required qualifications
- 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.
- 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 in
Nice to have
- 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.
About the company
Sail Biomedicines is an Equal Opportunity Employer.