Head of PSC Process Development
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 Head of Pluripotent Stem Cell (PSC) Process Development, you will report to Head of Tech Ops, and provide the strategic leadership to establish and drive the execution of the organization. You will drive strategies for developing scalable manufacturing processes to support Sana’s PSC cell therapy pipeline. You will define and execute appropriate characterization, validation and tech transfer activities for differentiation manufacturing process throughout the product lifecycle.
What you’ll do
- Providing strategic and technical leadership in the development of innovative, scalable differentiation processes used for manufacturing of Sana’s PSC cell therapy pipeline, including cardiomyocytes, glial progenitor cells, pancreatic islet cells, etc.
- Providing strategic and technical leadership in the characterization, validation, tech transfer or oversight activities required to ensure successful execution of differentiation processes in manufacturing, including external CDMOs
- Develop the content of relevant the CMC sections of regulatory dossiers, supporting regulatory queries and inspections
- Championing and driving 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
- Building strong collaborations across functions within Sana with Research, Tech Sci, Development, other process development functions, analytical development, quality and regulatory groups to align activities to rapidly advance Sana’s PSC pipeline
- Actively engage in the scientific community to build the reputation and creditability to position Sana as a leader in the field
- Building 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 the function
- As a member of the Tech Ops leadership team, develop the organization strategy, champion the Sana culture and make it a great place to work
- 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
- PhD in a life scientific discipline or engineering field w 10+ yrs experience in academic research and/or industry.
- Expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees.
- Current scientific knowledge and latest technologies in areas of PSC process development
- Proven track-record of technical excellence in PSC cell culture fields as well as overall CMC product development
- Knowledge and industry expertise of advanced scientific principles, practices and standards to process and product development
- Demonstrated ability to successfully manage therapeutic programs throughout product life cycle from pre-IND through clinical development to commercialization stages
- Knowledge and understanding of the regulatory guidelines and working experience in the GMP environment
- 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 attract, develop talents
- Proven track-record of organizational leadership, functional buildup and management
What you should know
- Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC
How we work together
- 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 diverse workforce 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 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.
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, 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.