Sr. Engineer I, Manufacturing Science and Technology
$125k - $165k USD
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 a Sr. 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 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
- 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 $125,000 - $165,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
- 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
Get to know us
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 critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. 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’sBenefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.