Director, MSAT

Sana Biotechnology, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 200,000 - 250,000; Full time

Benefits offered by this job

401(k) Plan with employer match

Tuition Reimbursement

Employee Stock Purchase Plan

Commuter subsidy

Generous health coverage

Job summary

Sana Biotechnology, Inc. is hiring an MSAT Director to lead an MSAT team focused on Phase I manufacturing of PSC-derived pancreatic islet cells for type 1 diabetes. You will manage technology transfer to an external partner, oversee training, and drive documentation and investigations.

You will collaborate with Quality, External Manufacturing, and Supply Chain to ensure batch disposition and regulatory readiness, while mentoring a high-performing, cross-disciplinary team in a fast-paced setting.

Qualifications

• BSc in Chemical, Biological, or Biomedical Engineering with 10+ years or equivalent experience.
• >5 years of experience supporting early phase cell therapy manufacturing including technology transfers.
• Experience with cGMP requirements and working in a regulated environment (person-in-plant and GMP operator).
• Knowledge of PSC culture and differentiation biology toward pancreatic islets.
• Experience managing a team of 3+ direct reports.
• Detail-oriented with strong problem-solving, technical writing, and verbal communication skills.
• Ability to work in multidisciplinary teams, meet deadlines, and prioritize multiple projects.
• Aptitude for working in a fast-paced matrix environment.

Responsibilities

• Lead a team of 2–4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product.
• Partner with CDMO technical teams to achieve manufacturing readiness and address technical challenges.
• Oversee people-in-plant activities, operator training, documentation, and process execution.
• Author 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 including root cause analysis.
• Perform comparability studies with Research and PD teams to assess tech transfer success.
• Engage in constructive feedback to support growth and development of team members.
• Demonstrate ability to influence across multidisciplinary teams while prioritizing multiple projects.

Skills

Leadership

cGMP knowledge

Cell therapy knowledge

Problem solving

Documentation & writing

Multidisciplinary teamwork

Education

BSc in Chemical/Biomedical Engineering

Tools

DoE

Flow cytometry

RCA

Job description

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 Director, 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 lead an MSAT team responsible for the PSC seed train and differentiation to beta cells at an external partner. You will define and execute the technology transfer strategy in alignment with program timelines and provide your team with technical mentorship. Your team will provide technical coverage at an 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).

What you'll do

• Lead a team of 2-4 individuals supporting Phase I manufacturing of a PSC-derived pancreatic islet cell therapy product
• Partner with CDMO technical team to achieve manufacturing readiness and address technical challenges
• Oversee people-in-plant, manufacturing operator training, technical documentation, and process execution
• Author 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 including 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 10 yrs or equivalent combination of education and work experience
• >5 year experience supporting early phase cell therapy manufacturing including technology transfers
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
• Knowledge of PSC culture and differentiation biology to pancreatic islets
• Experience managing a team of >3 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 cryopreservation
• 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
• Experience with cell therapy process closure and automation
• Knowledge of single-use technologies as applicable to cell therapies
• 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 (Canada)
• 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 $200,000 and $250,000/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 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
• 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.