Sana Biotechnology
Sana Biotechnology, Inc. is a new company focused on creating and delivering engineered cells as medicine for patients.
Recent scientific advances make it possible to reprogram cells in the body or replace damaged cells and tissues, creating a new class of medicines to treat a broad array of diseases.
We are a team of scientists, clinicians and biotechnology veterans focused on creating an enduring company that makes meaningful medicines and will change how we approach treating disease.
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Senior Director, Regulatory Affairs
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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. We are seeking an accomplished and strategic Senior Director, Regulatory Affairs to shape global clinical regulatory strategy across our pipeline, with a particular focus on programs in Type 1 diabetes, oncology, and autoimmune disease. This role is ideal for a seasoned regulatory leader who is excited by science‑driven development, cross‑functional collaboration, and advancing therapies for serious diseases.
You will develop and execute comprehensive regulatory strategies for clinical‑stage programs, guide teams on global regulatory requirements, and help shape the long‑term regulatory vision for the portfolio from Phase 1 to commercialization. Clinical-stage regulatory experience in our therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies is preferred. Experience in regulatory operations and/or ex-US submission planning are also considered beneficial for the role. This position reports to the Vice President, Head of Regulatory Affairs and would work out of Sana’s offices in Cambridge (preferred), South San Francisco, or Seattle.
What you’ll do
- Direct clinical regulatory strategies for assigned programs, with emphasis on Type 1 diabetes, oncology, and autoimmune disease assets.
- Create regulatory development plans, including key milestones, registration strategies, health authority engagement plans, expedited pathways, pediatric development, and risk assessments.
- Partner closely with Clinical Development, CMC Regulatory Affairs, Clinical Operations, Safety, Technical Operations, and Program Leadership.
- Lead and/or oversee global regulatory submissions and health authority interactions/meetings.
- Provide strategic input into labeling, target product profiles, and benefit‑risk considerations.
- Serve as a senior regulatory representative on cross‑functional program teams.
- Lead regulatory operations improvement efforts to ensure submission quality, compliance, and efficiency.
- Proactively identify regulatory risks and mitigation strategies.
- Monitor evolving regulatory policy in Sana’s therapeutic areas of focus and for cell/gene therapy modalities.
- Support development of internal regulatory processes.
- Mentor junior regulatory staff.
What we’re looking for
- Bachelor’s degree required, advanced degree in relevant scientific field preferred.
- 10+ years of regulatory affairs experience in biopharmaceutical industry; experience with cell and/or gene therapy products highly desirable.
- Demonstrated success in preparing and leading IND/CTA submissions, pivotal-stage amendments, BLA/MAAs, and any associated regulatory interactions.
- Clinical-stage regulatory experience in Sana’s therapeutic areas of focus (Type 1 diabetes, oncology, autoimmune disease) and cell/gene therapies preferred.
- Demonstrated ability to lead regulatory strategy through complex decision points and influence cross-functional teams at the senior level.
- Demonstrated ability to collaborate productively across a broad array of functional areas, as well as raise and entertain different points of view and regulatory options.
- Experience in regulatory operations, and/or ex-US submission planning beneficial, though not required.
- Strong understanding of FDA, EMA, and international guidelines.
- Excellent oral and written communication skills.
- Ability to work from Sana offices in Cambridge, MA is preferred; will consider candidates who can work from our offices in South San Francisco, CA or Seattle, WA.
What will separate you from the crowd
- Deep motivation to advance therapies for people with serious unmet needs.
- Intellectual curiosity and scientific rigor.
- Strong skills in matrix leadership, influencing without direct authority
What you should know
- The base pay range for this position at commencement of employment is expected to be between $275,000 and $325,000/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.
Ready to apply?
Apply to Sana Biotechnology
Senior Director, Late Stage Cell Therapy Process Development
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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 want to challenge status quo, and who lead with the desire to translate novel ideas into clinical and commercial product. As the Senior Director, Late-Stage Cell Therapy Process Development, you will report to the Head of Process and Analytical Development and provide strategic, technical leadership for late stage process development of a PSC-derived islet product for Type 1 diabetes. You will build and manage a high performing process development team to develop commercial ready manufacturing processes. You will play a critical role in advancing our pipeline through pivotal process development, technology transfer, process characterization, and commercial readiness, ensuring robust, scalable, and compliant manufacturing processes. Cool Stuff! This role will require onsite leadership in Cambridge, MA.
What you’ll do
- Partner closely with Research to develop 3D stem cell seed train and differentiation processes, including integration of bioreactors and automated and closed technologies and drug product (DP) process-enabling studies including formulation, fill/finish, and cryopreservation.
- Lead late stage process development for PSC-derived products, ensuring scalability, robustness, quality and regulatory compliance.
- Lead process characterization and validation activities, leveraging design of experiments (DoE) and Quality by Design (QbD) approaches and support process performance qualification (PPQ).
- Establish and execute a comparability strategy for pivotal process changes.
- Enable technology transfer to CDMOs or internal manufacturing, providing technical input and ensuring successful implementation.
- Author and review CMC sections of regulatory submissions (e.g., IND, BLA) and support regulatory Q&A and inspections.
- Collaborate and influence partners across multidisciplinary teams (e.g. Research, Analytical Development, Quality, Regulatory, Manufacturing, Clinical and Supply Chain) to execute on CMC deliverables for pivotal and commercial.
- Hire, mentor and develop a team of engineers, fostering a culture of trust, curiosity, scientific rigor, collaboration, and continuous improvement across a fast-paced performance driven environment.
- Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work.
What we’re looking for
- Ph.D. in Biochemical Engineering, Chemical Engineering, or related discipline with a minimum of 10 years experience in cell therapy process development (including >5 years late stage development), with at least 5 years in a leadership role.
- Hands-on experience with perfusion and single use bioreactor systems at various scales from benchtop to pilot/production scale and technologies that enable closed and automated cell therapy manufacturing.
- Knowledge of stem cell biology and 2D/3D stem cell expansion and differentiation, including raw material selection for GMP manufacturing.
- In depth knowledge and experience with application of engineering principles, DoE and QbD approaches to enable bioreactor scale up and scale down model development.
- Experience with risk and root cause analysis and tools (e.g. FMEA, Ishikawa).
- Knowledge of cGMP, and quality and regulatory expectations for commercial cell therapy and/or biologics products.
- Experience supporting regulatory submissions, Q&A and audits/inspections.
- Experience supporting tech transfer of a cell therapy process to manufacturing.
- Strong influencing skills and ability to work in a matrixed, fast paced environment with evolving roles and responsibilities.
- Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization.
What will separate you from the crowd
- > 10 years direct experience developing cell therapy processes from pre pivotal to commercial.
- Experience with optimizing protocols to generate stem cell derived islets
- Experience with PSC differentiation at >10 L in bioreactors
- Knowledge of media development including analytical tools to evaluate spent media and regulatory expectations for raw materials.
- Knowledge of process analytical technology (PAT) and analytical methods for deep characterization of stem cell derived products
- Strong track record of identifying and implementing novel cell therapy manufacturing technologies into GMP.
What you should know
- The base pay range for this position at commencement of employment is expected to be between $250,000 and $300,000/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.
Ready to apply?
Apply to Sana Biotechnology
Associate Director, External Manufacturing
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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 want to challenge status quo, and who lead with the desire to work on novel ideas. As an Associate Director, External Manufacturing you will report to the Executive Director, External Manufacturing to oversee day-to-day operational performance of key Sana contract development and manufacturing organizations (CDMOs). This will include coordinating and driving activities for pre-clinical and clinical phase drug substance (DS) and/or drug product (DP) manufacturing for Sana’s cell and gene therapy programs at 3rd party CDMOs. You will be an essential business partner within Technical Operations and will support Sana's manufacturing strategy to bring Sana's pipeline to patients across the world.
What you’ll do
- Acts as primary liaison and relationship manager between Sana Technical Operations and the CDMO to ensure timely delivery of high quality pre-clinical and clinical CGT product(s)
- Responsible for adherence to project schedule(s)
- Implement and execute governance structure with CDMO(s)
- Develops and oversees budget(s) for project(s) under their purview, including contributing to internal Sana budgeting activities and ensuring CDMO performance to financial plan in collaboration with Sana accounting.
- Partner with our technical departments to help ensure success of tech transfer activities from Sana to the CDMO partner.
- Monitors technical transfer and production campaign activities and reports on CDMOs performance against plans
- Identifies, notifies, and/or escalates risks and issues that may affect project timelines, resource requirements, finances, or business relationships
- Executes strategies that drive effective operational performance and service levels at contract organizations
- Negotiates and facilitates approval of contracts including proposals, master supply agreements, work orders, and changes of scope.
- Effectively communicates project, performance, and resource issues to management and within project teams
- Ensure CDMOs deliver to support Sana’s business needs including ensuring flexibility to accommodate changing program timelines and compliance with GMP practices as well as Sana's quality expectations
What we’re looking for
- Bachelors degree with 5+ years plus of outsourced clinical and/or commercial manufacturing experience in the biotech/pharmaceutical industry
- Knowledge and understanding of the regulatory guidelines and working experience in the GLP and GMP environment, including knowledge of cGMP quality systems
- Experience operating in early-stage clinical to commercial environments
- Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers.
- Proven ability to problem solve, build strong relationships, and to organize effectively
- Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
- Results-oriented and demonstrated focus on achieving business results. Experience with project team meetings, cross-functional communication, supporting decision making, influencing outcomes, and ensuring alignment among internal and external stakeholders
- Successful track record of developing cooperative, productive relationships across all functions with people at all levels within and external to the organization
- High degree of self-motivation
- Ability to quickly adapt to changing business conditions
What will separate you from the crowd
- Prior experience working with cell and gene therapy CDMOs
What you should know
- 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
- Up to 25% travel (domestic and/or international)
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.
Ready to apply?
Apply to Sana Biotechnology
Associate Director, MSAT
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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.
Ready to apply?
Apply to Sana Biotechnology
Director, MSAT
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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 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)
- 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 $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 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.
Ready to apply?
Apply to Sana Biotechnology
MSAT Engineer
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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 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). You will support technology transfers to external manufacturing partners. This will include authoring sections of process descriptions and master batch records. You will travel to the manufacturing partner to train operators and provide in-suite support as person-in-plant during phase 1 clinical manufacturing. You will participate in investigations leveraging RCA tools. You will compile run summaries, track process performance indicators, and periodically update stakeholders on manufacturing progress.
What you’ll do
- Support technology transfers and author technical documents including reports, standard operating procedures, master batch records, and work instructions
- Travel to external manufacturing partners to serve as person-in-plant, 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 root cause analysis
- Collaborate with Research and PD teams to learn and document the process, and execute studies in the PD lab
- 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
- Bsc. in Chemical, Biological, or Biomedical Engineering plus 4 yrs or MSc plus 2 yrs or equivalent combination of education and work experience
- >1 year experience supporting early phase cell therapy manufacturing
- Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator
- 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 culture and differentiation biology to pancreatic islets
- Experience with key cell therapy equipment and unit operations to support phase 1 clinical trials
- 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
- Excellent technical writing skills, including drafting technology transfer packages
- Familiar with data analysis tools such as R, Python, JMP and FlowJo software
What you should know
- Travel to the manufacturing site up to 50% of the time (Texas and Canada)
- 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 $120,000 and $150,000/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.
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Apply to Sana Biotechnology