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 an MSAT Associate Director, you will report to the Executive Director of MSAT to support manufacturing of Sana’s stem cell-derived pancreatic islet cell program for persons with type 1 diabetes (SC451). You will lead an MSAT team responsible for the pancreatic cell maturation and aggregation process to generate DP at an external manufacturing partner. You will define and execute the technology transfer strategy in alignment with program timelines. Your team will provide technical coverage at the external manufacturing partner throughout the phase I manufacturing campaign including people-in-plant, executed batch record review, investigations, and batch summaries. You will collaborate with internal partners across Quality, External Manufacturing, and Supply Chain to complete batch disposition. You will draft applicable CMC sections of regulatory documents (IND module 3). You will provide your team members with technical guidance and mentorship.

What you’ll do

Lead a team of 1-2 individuals supporting phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
Partner with CDMO technical team to achieve phase I manufacturing readiness and address manufacturing challenges
Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
Draft CMC sections for regulatory filings (IND module 3) and other technical documents
Collaborate with Quality to close deviations, analyze manufacturing trends, and recommend process improvements
Lead investigations and troubleshoot process execution challenges by applying root cause analysis
Perform comparability studies in collaboration with Research and PD teams to assess technology transfer success
Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
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
Innate ability to assess talent that will help grow the organization and add to Sana’s culture

What we’re looking for

BSc. in Chemical, Biological, or Biomedical Engineering plus 8 yrs or equivalent combination of education and work experience
>3 year experience supporting early phase cell therapy manufacturing including technology transfers
Well versed with cGMP requirements and experience working in a regulated environment, including as person-in-plan and/or GMP operator/supervisor
Experience operating perfusion bioreactors and with fill/finish unit operations
Knowledge of PSC culture and differentiation biology to pancreatic islets
Experience managing a team of >2 direct reports
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

Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials including PBS bioreactor
Familiarity with cell therapy drug product development, including stability studies
Working knowledge of statistical design of experiments (DoE) and RCA
Experience working in grade B / ISO 7 cleanroom
Knowledge of single-use technologies applicable to cell therapies
Experience with process closure and automation
Understanding of analytical methods such as flow cytometry
Familiar with data analysis tools such as R, Python, JMP and FlowJo software

What you should know

Travel to the manufacturing site ~25% of the time (Texas)
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 $170,000 and $210,000/year; 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’s Benefits 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.

Associate Director, MSAT

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