Senior Engineer II/Associate Director, Cell Therapy 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 Senior Process Engineer, you will report to the Sr. Director of Cell Therapy Process Development and drive late stage process development of allogeneic chimeric antigen receptor T (CAR T) cells from post-FIH through commercialization. The Sr. Process Engineer will lead a team of subject matter experts focused on enabling process improvements and automation of multiple integrated unit operations starting from cell isolation through expansion, gene editing, lentiviral transduction, and cryopreservation. The candidate will provide guidance on implementation of QbD principles in process development, establishing process control strategies, and process life cycle management. The candidate will lead a multidisciplinary group of up to 2 engineers and research associates to execute the development plan and support manufacturing campaigns. This role will collaborate closely with multiple cross-functional teams including Analytical Development, Research, Supply Chain and External Manufacturing to coordinate critical deliverables. The individual will also maintain a focus on innovation and process improvements to develop next generation allogeneic T cell manufacturing processes.

What you’ll do

• Serve as process SME for an allogeneic CAR T cell program
• Define life cycle management and establish process control strategies in close collaboration with CMC leads
• Lead and implement QbD principles to process development to identify robust operating regions within phase-approach pre-defined acceptance criteria per ICH guidelines
• Lead team to identify opportunities for process improvements including new bioprocess technologies and automation to enable commercial readiness
• Lead team in execution of the allogeneic CAR T cell therapy process development plan to ensure effective progression of CMC timelines
• Mentor, train, and motivate a group of engineers and research associates to plan, execute and analyze experiments
• Provide expert technical opinions to justify process development decisions
• Author, review, and approve technical documentation including reports, process descriptions, SOPs, and MBRs
• Support internal and external process transfers
• Draft and review technical sections to enable regulatory filings
• Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
• Demonstrate the 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 Chemical, Biological or Biomedical Engineering plus 2 years of industry experience or equivalent. BA and/or MS plus 7+ yrs or equivalent combination of education and work experience.
• >2 year of progressive experience in cell therapy process development, preferably with clinical and commercial stage T cell therapy processes with focus on cell culture
• Proven ability to lead a team of junior engineers and research associates
• Experience designing and scaling key cell therapy unit operations, especially T cell cultures within bioreactors
• Strong track record of applying fundamental engineering and scientific principles to process design, modeling, and characterization
• Well versed with cGMP requirements and working in a regulated environment
• Advanced knowledge of immunology including T cell biology
• Excellent technical written and oral communication skills
• Effective collaborator with an agile mindset to thrive in a fast-paced, multi-site, team-oriented organization
• Prior experience managing ≥1 direct report
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with process characterization of T cell isolation, lentiviral transduction, gene editing, cell harvest and cryopreservation unit operations design and model scaling
• Well versed with current cell therapy manufacturing platforms
• Working knowledge of statistical design of experiments (DoE)
• Experienced in establishing robust operating regions within phase-approach pre-defined acceptance criteria
• Knowledge designing and quali