Executive Director, PSC Process Development

As the Head of Pluripotent Stem Cell (PSC) Process Development at Sana Biotechnology, you will play a crucial role in driving the strategic leadership and execution of the organization. Your main responsibility will be to develop scalable manufacturing processes to support Sana's PSC cell therapy pipeline. Additionally, you will oversee characterization, validation, and tech transfer activities for differentiation manufacturing processes. This role requires strong collaboration with various functions within Sana and external partners, as well as active engagement in the scientific community. Ultimately, you will be responsible for building a world-class team and ensuring the successful advancement of Sana's PSC pipeline.

• Provide strategic and technical leadership in the development of innovative, scalable differentiation processes used for manufacturing of Sana's PSC cell therapy pipeline
• Provide strategic and technical leadership in the characterization, validation, tech transfer or oversight activities required to ensure successful execution of differentiation processes in GMP manufacturing, GLP tox studies, and GMP MCB generation including oversight of external CDMOs
• Develop the content of relevant CMC sections of regulatory dossiers, supporting regulatory queries and inspections
• Champion and drive technical innovations for scalable PSC manufacturing processes, either in bioreactors or adherent vessels, include both internal and external innovation through collaborations with academic research institutions and suppliers
• Build strong collaborations across functions within Sana with Research, Development Sciences, and Tech Ops functions (process development, analytical development, quality and regulatory) to align activities to rapidly advance Sana's PSC pipeline
• Align with Platform Team Leader to ensure deliverables of the program are met and ensure successful execution of PSC gene editing, expansion, banking and differentiation processes in manufacturing
• Actively engage in the scientific community to build the reputation and credibility to position Sana as a leader in the field
• Build a world-class team that will execute on the defined strategy
• Develop and mentor a high-performing team of scientists and engineers with a vision of setting industry-leading scientific standards and innovation
• Manage the functional component of business planning and own budget accountability for this group
• Help develop the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work as a member of the Tech Ops Cell Therapy Process Development Leadership Team
• 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
• Assess talent that will help grow the organization and add to Sana's culture
• Oversee the transfer of a cell therapy process internally and externally for cGMP manufacturing
• Deliver results consistently and effectively
• Communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers
• Adapt quickly to changing business conditions
• Attract and develop talent
• Provide organizational leadership, functional buildup, and management

• PhD in a life Scientific Discipline or engineering filed with 15+ years of experience in academic research and/or industry
• Expert knowledge of cell therapy process development principals and concepts and is a thought leader; has experience managing department(s) with senior employees
• Current scientific knowledge of latest technologies in PSC process development, particularly scalable cell culture systems such as bioreactors, and DOE experience
• Proven track-record of technical excellence and industry experience with PSC process development approaches as well as overall CMC product development
• Demonstrated ability to successfully manage therapeutic programs throughout product life cycle from pre-IND through clinical development to commercialization stages
• CMC team leadership experience – demonstrated ability in a fast-paced, multifaceted matrixed team environment, ability to comprehend the big picture and also strategically drive execution details for CMC deliverables
• Knowledge and understanding of regulatory guidelines and working experience in a cGMP environment
• Experience overseeing the transfer of a cell therapy process internally and externally for cGMP manufacturing
• Ability to deliver results consistently and effectively
• Ability to communicate across all levels of an organization and efficiently coordinate activities with both internal and external customers
• High degree of self-motivation
• Ability to quickly adapt to changing business conditions
• Demonstrated track record in attracting and developing talent
• Proven track-record of organizational leadership, functional buildup and management
• Experience with PSC single cell cloning, CRISPR-Cas9 gene editing (or equivalent) and/or reprogramming
• Knowledge of islet biology

• 100% coverage of employee health coverage
• Various paid time off benefits, such as holidays, vacation, sick time, and parental leave
• Short- and long-term disability coverage
• Employer paid basic life insurance
• Additional voluntary life insurance protection
• Financial wellness programs, including financial planning resources
• 401(k) Plan with an immediately vested employer match
• Tuition Reimbursement and Student Loan Repayment
• Employee Stock Purchase Plan
• Commuter subsidy
• Variety of wellness offerings to support each person individually