MSAT Engineer

Sana Biotechnology • Cambridge, MA

3h • $120,000 - $150,000

About The Position

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.

Requirements

• 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

Nice To Haves

• 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 FlowJo software

Responsibilities

• 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

Benefits

• For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable.
• We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
• For more details on our benefits, visit Sana’s Benefits Portal.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level