About the role
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 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.
What you’ll do
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
What we’re looking for
BSc. and/or MS in Chemical, Biological, or Biomedical Engineering plus 7 yrs or equivalent combination of education and work experience
>4 years of experience with mammalian cell culture, including 1 year in cell therapy
Experience leading technology transfers to an external CDMO, preferably of cell therapy processes
Experience with adherent and suspension PSC culture and cell differentiation processes
Detail-oriented with good problem-solving, technical writing and verbal communication skills
Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
What will separate you from the crowd
Knowledge of PSC and pancreatic islet biology
Experience scaling-up a cell therapy manufacturing process to support phase 1 clinical trials
Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
Working knowledge of statistical design of experiments (DoE) and 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
Familiar with R, Python, JMP and FlowJo software
What you should know
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
The base pay range for this position at commencement of employment is expected to be between $160,000 and $190,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a workforce with varied…