Senior Engineer, MSAT

Sana Biotechnology•Cambridge, MA

11d•$160,000 - $190,000

About The Position

Sana Biotechnology is hiring a Senior MSAT Engineer to support manufacturing of its stem cell-derived pancreatic islet cell program for people with type 1 diabetes (SC451). In collaboration with the Research team, the engineer will scale, close, and automate the process in preparation for Phase 1 clinical manufacturing and lead technology transfers to the manufacturing site. The role also provides onsite support during manufacturing runs, including serving as person-in-plant. The position combines process development, technology transfer, manufacturing support, technical documentation, troubleshooting, and continuous improvement. It involves travel to the manufacturing site approximately 25% of the time, laboratory work approximately 25% of the time, some weekend work, and work in a cleanroom environment. The role requires lifting up to 25 pounds. The expected base pay range at commencement is $160,000 to $190,000 per year. Actual base pay may vary based on factors including market location, job-related knowledge, skills, and experience.

Requirements

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

Nice To Haves

Knowledge of PSC and pancreatic islet biology.
Experience scaling up a cell therapy manufacturing process to support Phase 1 clinical trials.
Knowledge of cGMP requirements and work in a regulated environment, including experience as person-in-plant and/or GMP operator.
Working knowledge of statistical design of experiments (DoE) and root cause analysis (RCA).
Operating knowledge of bioreactors, controlled-rate freezers, and other cell therapy equipment.
Understanding of analytical methods such as flow cytometry.
Experience developing scale-down models.
Excellent technical writing skills, including drafting IND sections.
Familiarity with R, Python, JMP, and FlowJo software.

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, and work instructions.
Collaborate with Research to learn and document the process and execute studies in the process development 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 root cause analysis (RCA).
Engage and influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines.
Promote curiosity, scientific rigor, and problem-solving in a fast-paced, performance-driven environment.