Executive Director, 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 translate novel ideas into clinical product. As the Head of Pluripotent Stem Cell (PSC) Process Development, you will report to the Head of Process Development and provide strategic leadership to develop, establish, and drive the execution of the organization. You will build a high performing process development team to develop scalable manufacturing processes to support Sana’s stem cell therapy pipeline. You will define and execute process development and tech transfer activities to enable PSC expansion and differentiation in GMP manufacturing throughout the product lifecycle. You will represent CMC at Program Core Team. Cool Stuff! This role will require onsite leadership in South San Francisco, Seattle, or Cambridge.
What you’ll do
- Provide strategic and technical CMC leadership for developing innovative, scalable expansion and differentiation processes to manufacture PSC derived cell therapy products
- Provide oversight of activities required to ensure successful transfer and execution of differentiation processes in GMP manufacturing, including oversight of external CDMOs
- Drive technical advancements through collaborations with suppliers, academic research institutions and industry consortiums
- Hire, develop and mentor a talented team of scientists and engineers with a vision of setting industry-leading scientific standards and innovation
- Drive curiosity, scientific rigor and leverage excellent problem-solving skills across a fast-paced performance driven environment
- Develop the content of relevant CMC sections of regulatory dossiers, support regulatory interactions and queries
- Serve as a cross-functional, matrix CMC leader for PSC programs. Develop CMC plans for clinical development, manufacturing, supply and regulatory strategy, risk management and timelines etc.
- Collaborate with Sana colleagues in Research, Translational Sciences, Clinical and Technical Operations and effectively manage stakeholders across the organization to align strategy and approach to rapidly advance Sana’s PSC pipeline
- Partner with the Program Team Leader to ensure achievement of program deliverables
- Manage the functional component of business planning and own budget accountability for the group
- As a member of the Tech Ops Process Development Leadership Team, contribute to developing the organization strategy, cultivate opportunities for career development, champion the Sana culture and make it a great place to work
What we’re looking for
- PhD in a life Scientific Discipline or engineering filed with 15+ years of experience in academic research and/or industry.
- Deep expertise and industry experience in cell therapy process development principals including DOE and experience with current technologies in PSC process development and manufacturing, particularly scalable stem cell culture systems such as bioreactors
- Experience overseeing the transfer of a cell therapy process for cGMP manufacturing to internal facility and external CDMO with a quality/compliance mindset
- Knowledge and understanding of regulatory guidelines and experience supporting regulatory filings and interactions
- CMC team leadership experience managing cell therapy programs through product life cycle from pre IND through clinical and commercialization stages – propensity to thrive in fast-paced, multifaceted, matrixed team environment, ability to comprehend the big picture and also strategically drive execution details for CMC deliverables
- Highly proficient at communicating and influencing individuals across all levels of an organization and multidisciplinary teams while prioritizing multiple projects and meeting deadlines
- Demonstrated ability to mentor scientists and engineers, engage in crucial conversations by providing and receiving feedback to support the growth and development of direct reports
- Innate ability to assess talent that will help grow the organization and add to Sana’s culture
- Proven track-record of organizational leadership, functional buildup and management
What will separate you from the crowd
- Knowledge of islet biology and differentiation
- Experience with PSC single cell cloning, CRISPR-Cas9 gene editing (or equivalent) and/or reprogramming
What you should know
- The base pay range for this position at commencement of employment is expected to be between $290,000 and $340,000/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
- 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 (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.