Executive Director, PSC Process Development

1 month ago

Cambridge Cambridgeshire, United Kingdom Sana Biotechnology Full time

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.
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