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 

About the role

As the Manager of Facilities & Engineering and Site Operations Lead for the Cambridge site, you will serve as a site Facilities and Engineering leader responsible for driving strategic facility, asset, and site wide operational programs across two locations. You will provide clear direction, influence decisions, and ensure that all facilities, engineering, and teams work cohesively to support day-to-day operations and corporate objectives.

In partnership with the Facilities and Engineering leadership, you will translate organizational priorities into actionable plans, communicate expectations clearly to stakeholders, and cultivate a high trust, high performance environment. This role requires a leader who is proactive, systems minded, and able to align cross functional teams and external partners around shared goals.

What you’ll do

Operational Leadership

• Lead the development and execution of facility, equipment, and operational strategies that advance site readiness, reliability, safety, compliance, and efficiency.
• Drive short and long range planning for the site’s assets, capital improvements, the maintenance/calibration program, and operational continuity.
• Oversee implementation and continuous improvement of programs covering the management of facilities, equipment maintenance and calibration, building systems and utilities, and project management and execution.
• Lead the development and execution of Facilities and Engineering initiatives to support scientific objectives and corporate strategies.
• Participate with leadership in the development of site Facilities and Engineering budgets, and management of established budgets.

Communication and Execution

• Manage day to day operations for both facilities, ensuring that work is properly prioritized and performed in accordance with business, safety, and quality requirements.
• Establish and monitor operational metrics, customer service standards, and performance indicators to promote transparency and continuous improvement.
• Act as the primary point of contact for site Facilities and Engineering, ensuring clear, timely, and solution oriented and transparent communication.
• Collaborate on contract negotiations, vendor selection, and provide vendor oversight to ensure operational reliability and cost effective, compliant service delivery.
• Collaborate with other operations functions within Sana (Site Lead, IT, Procurement, Facilities & Engineering, People, Legal) to drive solutions for Cambridge site needs.
• Build strong relationships with internal partners, external vendors, and contractors to ensure business and quality requirements are fulfilled.
• Partner with Environmental Health and Safety and Business Leaders to support emergency response plans and events.
• Facilitate site wide messaging around operational changes, space planning, project impacts, and service disruptions.
• Oversee facility and equipment service contract administration, planning and scheduling, and procurement of parts, tools, and equipment.

What we’re looking for

• Bachelor’s degree in engineering or related field.
• 7+ years of experience leading facilities, engineering, or lab operations in biotechnology or related industries.
• Demonstrated ability to influence stakeholders, and lead through change in a fast-paced, dynamic environment.
• Exceptional communication skills—able to simplify complex operational problems to drive clarity and align diverse audiences around shared objectives.
• Proven ability to manage competing priorities while maintaining strong partnerships across scientific, operational, quality, and business teams.
• Deep understanding of facility and utility systems (HVAC, gases, DI water, electrical, etc.), and asset lifecycle management in GxP environments.
• Sound judgment and troubleshooting skills and the capacity to resolve diverse problems effectively and in alignment with business needs
• Experience managing preventive maintenance and calibration programs, capital projects, vendor relationships, and cross‑site operational systems.
• Strong analytical and problem‑solving capabilities, with the ability to provide fit for purpose solutions.
• Embodies Sana’s core values: Lead from every seat, Thrive as a team, Make it happen.
• Demonstrates sound judgment, proactive thinking, and a commitment to a safe, compliant, and collaborative workplace.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $140,000 and $160,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

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.

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, Project Management, you will report to the program team lead (PTL) and work directly with our functional leaders to coordinate research, development, and manufacturing activities for Sana’s in vivo CAR T cell engineering program. You’ll help us target those small details that unlock big successes. This is a hybrid role that requires onsite presence at least 3 days a week in Cambridge.

What you’ll do  

• Partner with the PTL to manage a complex, cross-functional in vivo CAR T cell engineering program from preclinical through clinical development.
• Owner of project plan templates, tools, and project management best practices to organize and facilitate program team activities.
• Create and maintain a comprehensive project timeline and dashboard to monitor program performance, identify risks, and implement mitigation strategies in real time.
• Maintain close collaboration and great communication with internal and external key stakeholders to track program milestones where critical path risks at CDMO, CTL, and CRO are identified, escalated, and resolved promptly.
• Manage development and program budget.

What we’re looking for

• Batchelor’s degree in life sciences, biotechnology, or engineering field
• 6+ years of experience in pharmaceutical or life sciences industry, including 3+ years direct project management experience
• Proficiency in project management methodologies and tools such as Smartsheet and MS Timeline
• Excellence in stakeholder management with track record of working in matrix organization and influencing across multi-site, multi-function project teams
• Flexibility to work with external vendors in various time zones
• Strong understanding of drug development lifecycle and compliance in biotechnology
• Ability to operate effectively in a dynamic start-up environment that requires learning agility and the ability to plan and execute through ambiguity

What will separate you from the crowd  

• PM Experience in Cell and Gene Therapy development
• PMP certification
• Global experience

What you should know      

• The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

About the role

We are seeking a highly organized and motivated Corporate Paralegal to join the collaborative Legal team of a publicly traded biotechnology company. This is an is an excellent opportunity for a paralegal in the early stage of their career to gain hands-on experience across a broad range of corporate, contracts, securities, and governance matters in a fast-paced, mission-driven environment.

The Corporate Paralegal will be located in our Cambridge, MA office and will be expected to be in the office at least 3 days a week. The Corporate Paralegal will report to the SVP, Head of Intellectual Property, and work closely with the VP, Senior Corporate Counsel and other members of the Legal team, the Finance team, and executive management. This role will support day-to-day legal operations and manage a wide range of corporate and legal matters, including contracts, corporate governance, securities, and compliance matters for Sana.

What you’ll do

Contract Management, Legal Billing, and Operations

• Support contract lifecycle management for of a wide range of day-to-day and complex contracts typical of a biotech or pharmaceutical organization.
• Work with Contracts team members to maintain company’s software-based contract management system (Agiloft) and ensure accurate recordkeeping.
• Coordinate with internal clients and external parties to facilitate contract execution and related matters.
• Maintain and manage company’s legal billing processes, including managing its legal billing system (SimpleLegal), including data entry.
• Support improvements to legal department processes, templates, and workflows.
• Provide general paralegal and administrative support to the legal team on a wide range of corporate matters.

Corporate Governance and Securities

• Support corporate governance processes, including preparation and organization of materials for Board of Directors and committee meetings, including agendas, resolutions, minutes, consents and other documentation, maintenance of the corporate records and minute books, maintenance of the company’s online Board of Directors portal, and officer and director onboarding and offboarding.
• Support SEC filings, including 10-K, 10-Q, 8-K, and proxy statement, including assistance with preparation of disclosures and tables, maintenance of filings calendars, preparation and management of D&O questionnaires, and preparation and filing of Section 16 reports.
• Support planning and logistics for annual meeting of stockholders, including vendor communication, calendars, and meeting materials.
• Manage and maintain company’s state qualifications, including new applications, withdrawals, and annual reporting and related activities necessary to maintain qualifications.
• Collaborate with Finance and People teams to support equity administration, including managing execution of consents for Equity Incentive Committee, and review and execution of 10b5-1 plans.

General Corporate and Cross-Functional Support

• Help develop, streamline, implement and maintain processes and policies across the organization, including those related to securities reporting, compliance, equity administration, and contracts.
• Support strategic transactions, including due diligence, data room administration, document preparation, and post-closing administration.
• Other tasks and duties as assigned.

What we’re looking for

• BS/BA degree
• Paralegal certificate or coursework preferred but not required
• 0-2+ years of experience as a paralegal, legal assistant, or related legal or compliance role (law firm or in-house experience a plus, but not required).
• Interest in corporate law, public company compliance, and the life sciences and biotechnology industries.
• Professional discretion and ability to handle confidential and sensitive matters.
• Strong attention to detail and organizational skills and ability to work independently or with a team, as necessary, to meet critical deadlines.
• Strong project management skills; flexible and capable of managing and prioritizing multiple duties and projects within specified time frames.
• Excellent communication skills, customer orientation, and resilience
• Ability to develop understanding of and ensure compliance with Legal department and cross-functional requirements, processes and procedures.
• Self-motivated, flexible, collaborative, eager to learn, and interested in working on a wide range of legal, contracts, governance and compliance matters.
• Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Experience with billing, contract management systems, and Board of Directors portals is a plus but not required.

What you should know

• The base pay range for this position at commencement of employment is expected to be between $95,000 and $110,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

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)

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 a CMC Project Manager, you will report to Sr. Director, Supply Strategy. You will work directly with our CMC team leads to develop and deliver CMC project plans and with our functional leaders to improve our efforts to deliver a complex, innovative CMC portfolio. You will help us target those small details that unlock big successes and replicate them across programs.

What you’ll do

• Develop a master project plan using MS Project or Smartsheet. Based on task interdependencies, define CMC project critical path and establish monitoring mechanisms to align and correct any schedule modifications that impact the critical path.
• Publish regular dashboards to align team on project progress and any modifications to the critical path. Support the CMC team on enabling decisions and risk management.
• Partner with CMC Team Leaders to set and monitor CMC strategy and team goals. You will create and maintain the cross-functional CMC project plan and keep team activities and timelines on track.
• Support assembling and maintaining key CMC information to guide CMC execution (e.g. QTPP, risk assessment, decision and action item logs, etc.)
• Identify potential CMC risks, resource constraints, and conflicts that could impact program timelines; work with CMC lead and team members to develop and execute functional mitigation strategies, and to identify and develop options for CMC risks that rise to program level impact.
• Deliver consistent and high-quality CMC program management services to enable CMC team, overall program and project success by being strategic in project planning, team management, and process management.
• Ensure close collaboration and great communication with core program team PM to ensure that CMC plans deliver Sana program priorities and that critical path risks are identified, escalated, and resolved fast
• Help improve communication and help CMC teams learn from one another so that CMC teams and functions work together effectively to deliver Sana’s new medicines to patients

What we’re looking for

• Bachelor’s degree in relevant science or engineering field
• At least 6+ years’ experience in pharmaceutical or life sciences industry including 4+ years of CMC development or CMC project management experience
• Experience taking programs to INDs and pivotal INDa submission.
• Expert knowledge of Project Management methodologies, concepts, and tools
• Track record of working in matrix organization and influencing across multi-site, multi-function program teams
• Ability to operate effectively in a dynamic start-up environment that requires learning agility and the ability to plan and execute through ambiguity
• Ability to communicate strategic and technical concepts, plans, and tradeoffs effectively to stakeholders at many levels of the organization and from different technical functions or backgrounds

What will separate you from the crowd

• Experience with Cell and Gene Therapy CMC development
• Portfolio or multi-program PM experience
• PMP certification
• Lean Six Sigma or other certification in Operational Excellence

What you should know 

• The base pay range for this position at commencement of employment is expected to be between $165,000 and $205,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience 

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

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 Director, Contract Counsel, you will report to the SVP, Head of Intellectual Property to manage all aspects of contract operations, negotiation, review, and execution while advising the business on legal matters related to contracts. You will form close partnerships within our legal team and with internal clients to provide service-oriented support that helps get cutting-edge cell and gene therapies to patients.

What you’ll do

• Draft, review, and negotiate a broad range of contracts touching all areas of our business in research, development, and G&A, including sponsored and contract research, manufacturing, confidentiality, material transfer, consulting, advisory board, vendor, master services, purchasing, outsourcing, software, licensing, data-related agreements, and clinical trial agreements
• Coordinate contract management by overseeing our software-based contract lifecycle management system (CLM) and in the development and implementation of contract-related policies/procedures, template libraries, and standard language
• Work closely and collaboratively with all legal team members as part of an engaged and efficient team
• Advise internal business owners on the range of issues involved in contracting to provide practical problem-solving guidance and communicate potential business and legal risks
• Promote compliance with internal approval and financial controls regarding contract initiation and requisition
• Partner with IT and Legal stakeholders to maintain the CLM and train end-users effectively
• Provide internal training across the company regarding legal concepts, privacy matters, and contract-related policies
• Provide support on various compliance and privacy matters
• Provide support on all other matters requested by other members of the legal department, as needed

What we’re looking for

• A JD degree from an accredited law school and a license to practice in good standing in Massachusetts (or eligibility to practice as Registered In-House Counsel)
• 4+ years of experience as an attorney drafting and negotiating a wide variety of contracts within a high-growth biotech/pharmaceutical company or law firm equivalent
• Proven ability to analyze legal contractual terms and assess risks in complex business arrangements
• Strong verbal and analytical skills with a track record of making risk-appropriate decisions in line with company standards
• Demonstrated organizational skills necessary to manage multiple, parallel contract negotiations simultaneously while meeting shifting deadlines.
• A customer-service orientation and a positive attitude, balanced with honesty and integrity

What will separate you from the crowd

• Prior experience managing a CLM transition or significant optimization project
• Specific expertise in data privacy regulations as they relate to clinical and research contracts

What you should know

• The base pay range for this position at commencement of employment is expected to be between $225,000.00 and $275,000/year, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
• This role requires a high volume of written and verbal communication with internal stakeholders and external partners

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

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 the status quo, and who lead with the desire to work on novel ideas. You will join the Beta Islet Team at the Cambridge location to optimize 3D expansion and differentiation in stem cell (SC)-islet differentiation. As a Senior Scientist, you will execute optimization experiments critical to scaling up our differentiation process. The ideal candidate should have ample experience handling bioreactors and performing directed PSC differentiation in 3D. The ability to work in a highly collaborative environment and learn from each other will be essential to your success.

What you’ll do

• Execute routine 2D and 3D PSC expansion, passaging and directed SC-islet differentiation
• Design optimization experiments with the goal to achieve a highly scalable and robust 3D SC-islet differentiation process that is compliant to manufacturing standards
• Optimize the differentiation protocol to achieve highly pure on-target populations
• Hands-on experience with closed systems (tube welder, sealer, single-use assemblies)
• Expertise in controlled bioreactor setup, operation, automation, and process control (DO, pH, perfusion, agitation)
• Collaborate and communicate findings with other team members
• Maintain excellent scientific documentation and contribute to SOP development
• Assure compliance with all relevant lab safety and biosafety regulations
• Demonstrate Sana’s core values and the attributes that support these core values (Lead from every seat, Thrive as a team, Make it happen)
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team member
• 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

• PhD in Stem cell biology, biochemical/biomedical Engineering or related fields with 3-5 years of direct cell therapy industry experience
• Significantly experienced and knowledgeable in operating various types of bioreactors for suspension culture.
• Experienced with bioreactor control software, process development tools, or DOE-base optimization is preferred
• Significantly experienced in operating a closed system for cell culture
• Significantly experienced in Flow cytometry, Immunofluorescent staining,
• Proficient with standard flow cytometry and imaging software (e.g. FACSDiva, FlowJo, ImageJ, Halo, etc.) 

What will separate you from the crowd   

• Knowledge or direct experience in directed stem cell differentiation toward pancreatic islet lineage
• Proven ability to optimize differentiation yield and reproducibility across platforms
• Passion for GMP transition, automation, and continuous process improvement
• Strong cross-functional collaboration skills and enthusiasm for advancing cell therapies to the clinic
• Significant experience in operating large bioreactors (15L+) for cell therapy purposes
• Expertise in controlled bioreactor setup, operation, automation, and process control (DO, pH, perfusion, agitation)
• Proven ability to optimize differentiation yield and reproducibility across platforms

What you should know

• The base pay range for this position at commencement of employment is expected to be between $160,000 and $190,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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

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