Sr. Engineer I, Manufacturing Science and Technology (Tech Transfer Lead), Cambridge

Sr. Engineer I, Manufacturing Science and Technology (Tech Transfer Lead)

42 Days Old

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

The base pay range for this position at commencement of employment is expected to be between $140,000 - $160,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
Working safely on a predictable and regular basis is an essential job function for this position and the Company requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19
This position requires handling of healthy donor human blood products
Approximately 50% in-lab work
Some weekend work required
Travel up to 25% of the time

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 diverse workforce 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 100% of the cost for employee health coverage and offer generous 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.

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Location:: Cambridge

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