MSAT Engineer

Responsibilities

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

Requirements

• BSc in Chemical, Biological, or Biomedical Engineering with 4+ years experience, or MSc with 2+ years experience
• Over 1 year of experience supporting early phase cell therapy manufacturing
• Proficiency with cGMP requirements and working in a regulated environment
• Experience as person-in-plant and/or GMP operator
• Strong technical writing and problem-solving skills
• Ability to travel to manufacturing sites up to 50% of the time (Texas and Canada)

Preferred Qualifications

• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience with cell therapy equipment and unit operations for phase 1 clinical trials
• Working knowledge of statistical design of experiments (DoE) and RCA
• Experience working in grade B / ISO 7 cleanroom environments
• Understanding of analytical methods such as flow cytometry
• Familiarity with data analysis tools such as R, Python, JMP, and FlowJo

About the Company

Sana Biotechnology is focused on the potential of engineered cells as medicines, working to deliver novel cell-based therapies to patients with diseases like type 1 diabetes.