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.

Scientist I/Senior Engineer I, Pilot Lab Lead at Sendabiosciences | JobZoey