Engineer II, Manufacturing Science and Technology
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). In collaboration with the Research team, you will scale, close, and automate the process in preparation for phase 1 clinical manufacturing. You will support technology transfers to the manufacturing site and 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
- Collaborate with Research to learn and document the process, and execute studies in the PD lab
- Support technology transfers and author technical documents including reports, SOPs, master batch records, and work instructions
- Provide onsite support at the CDMO, 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 RCA
- Engage and influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
- Drive curiosity, scientific rigor, and problem-solving skills in a fast-paced environment
What we're looking for
Degree in Chemical, Biological, or Biomedical Engineering plus 6 years or MSc plus 4 years, or equivalent experience4 years of experience with mammalian cell culture, including 1 year in cell therapy
Experience with adherent and suspension PSC culture and differentiation processesDetail-oriented with good problem-solving, technical writing, and communication skillsAbility to work in multidisciplinary teams, meet deadlines, and prioritize projectsAptitude for working in a fast-paced, results-oriented environmentWhat will separate you from the crowd
Knowledge of PSC and pancreatic islet biologyExperience scaling-up cell therapy manufacturing for phase 1 trialsExperience with cGMP requirements and regulated environments, including as person-in-plant or GMP operatorKnowledge of statistical DOE and RCAOperating knowledge of bioreactors, freezers, and cell therapy equipmentUnderstanding of analytical methods like flow cytometryStrong technical writing skills, including drafting IND sectionsFamiliarity with R, Python, JMP, and FlowJoAdditional information
Travel to manufacturing site ~25%Work in a lab environment ~25%Lift up to 25 lbsWork within a cleanroom environmentBase pay range : $100,000 - $120,000 / year, varies based on experience and locationOur values and culture
Lead with honesty, understanding, and engagementFoster a diverse, inclusive, and connected teamPrioritize execution and resilient decision-makingAbout Sana
We believe diversity strengthens us and are committed to an inclusive workplace. We offer comprehensive benefits including health coverage, paid time off, disability insurance, life insurance, financial wellness programs, 401(k), tuition reimbursement, stock purchase plan, and wellness offerings. We are dedicated to a workplace free of discrimination and harassment. To perform this job successfully, you must be able to perform each responsibility satisfactorily, with reasonable accommodations available for individuals with disabilities.
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