Sr. Engineer I, Manufacturing Science and Technology

Role Summary

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who are passionate about delivering the possible to patients, and who lead with the desire to work on novel ideas. As a Sr. MSAT Engineer, you will report to the Executive Director of MSAT and support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). In collaboration with the Research team, you will scale, close, and automate the process in preparation for phase 1 clinical manufacturing. You will lead technology transfers to the manufacturing site. You will travel to the site to serve as person-in-plant during manufacturing runs.

Responsibilities

• Apply engineering principles to scale-up, close, and automate PSC-based cell therapy manufacturing processes
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with Research to learn and document the process, and execute studies in the PD lab
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Review executed batch records, collaborate with QA to close process deviations, analyze manufacturing trends, and recommend improvements
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Qualifications

• Required: MS in Chemical, Biological, or Biomedical Engineering plus 7 yrs or equivalent combination of education and work experience
• Required: >4 years of experience with mammalian cell culture, including 1 year in cell therapy
• Required: Experience leading technology transfers to an external CDMO, preferably of cell therapy processes
• Required: Experience with adherent and suspension PSC culture and cell differentiation processes
• Required: Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Required: Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Required: Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

Additional Requirements

• Travel to the manufacturing site ~25% of the time
• Work in a laboratory environment ~25% of the time
• Some weekend work required
• Lift up to 25 lbs
• Work within a cleanroom environment