MSAT Engineer

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 an 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).

You will support technology transfers to external manufacturing partners. This will include authoring sections of process descriptions and master batch records. You will travel to the manufacturing partner to train operators and provide in-suite support as person-in-plant during phase 1 clinical manufacturing. You will participate in investigations leveraging RCA tools. You will compile run summaries, track process performance indicators, and periodically update stakeholders on manufacturing progress.

• Support technology transfers and author technical documents including reports, standard operating procedures, master batch records, and work instructions
• Travel to external manufacturing partners to serve as person-in-plant, train manufacturing operators, and oversee process execution
• Review executed batch records, collaborate with QA to close process deviations, analyze manufacturing trends, and recommend improvements
• Support investigations to troubleshoot process execution challenges including root cause analysis
• Collaborate with Research and PD teams to learn and document the process, and execute studies in the PD lab
• 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

• Bsc. in Chemical, Biological, or Biomedical Engineering plus 4 yrs or MSc plus 2 yrs or equivalent combination of education and work experience
• >1 year experience supporting early phase cell therapy manufacturing
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
• 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

• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom
• Understanding of analytical methods such as flow cytometry
• Excellent technical writing skills, including drafting technology transfer packages
• Familiar with data analysis tools such as R, Python, JMP and Flow Jo software

• Travel to the manufacturing site up to 50% of the time (Texas and Canada)
• Work in a laboratory environment ~25% of the time
• Some weekend work required
• Lift up to 25 lbsWork within a cleanroom environment
• The base pay range for this position at commencement of employment is expected to be between $120,000 and $150,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

• 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

At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is…