About the role 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
