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Senior Director, Cell Therapy Process Development

Employer
Sana Biotechnology
Location
Seattle, WA; South San Francisco, CA
Start date
Dec 6, 2023

Job Details

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 Senior Director, Cell Therapy Process Development, you will guide and oversee late stage process development activities. You will mentor Process Engineers and Scientists to build a high-performing team. You will be responsible for later phase development of allogeneic CAR T cell processes including Phase 2 and beyond. You will define process characterization and PPQ strategy and support technology transfers to external/internal manufacturing sites. You will implement manufacturing strategies in collaboration with multidisciplinary teams from Research to Manufacturing and Quality to advance Sana’s cell therapy process to commercial readiness and improve patient outcomes.

What you’ll do

  • Lead and oversee a Process Development team to advance later stage programs, including process characterization
  • Work with CMC leads to draft IND and BLA sections
  • Drive process development initiatives across the organization
  • Support external and internal technology transfer activities at manufacturing sites
  • Identify and evaluate novel technologies to build best-in-class platforms
  • 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
  • Contribute to developing the organization strategy, cultivate opportunities for innovation and career development, champion the Sana culture and make it a great place to work

What we’re looking for

  • BSc in Science or Engineering with 12+ years of experience in process development or equivalent combination of education and work experience; at least 6 years leading a team
  • 5 years of cell therapy process development experience supporting early- and late-stage programs
  • Advanced technical knowledge of T cell biology and unit operations including isolation, expansion, bioreactors, lentiviral transduction, and gene editing
  • Ability to build, manage, and mentor a team of engineers and scientists
  • Prior experience with process characterization, DoE, QbD, and demonstrated abilities in risk analysis
  • Experience overseeing technology transfer of a cell therapy process internally and/or externally for cGMP manufacturing
  • Excellent organizational skills and an ability to prioritize to deliver results within fast timelines
  • Strong influencing skills and ability to work in a matrixed environment
  • Excellent written and verbal communication skills with ability to effectively communicate and partner with all levels of the organization

What will separate you from the crowd

  • Demonstrated track record driving cell therapy processes to commercial readiness, including a least 1 late stage, or commercial program
  • Working knowledge of late stage process development strategy including comparability, process characterization/validation and PPQ
  • Experience supporting internal and external tech transfers on fast timelines
  • Strong understanding of immunology and T cell biology
  • Deep understanding of cell therapy cGMP manufacturing, including Quality expectations
  • Statistical design of experiments (DoE), QbD, and knowledge of root cause analysis and tools (e.g. FMEA, Fishbone/Ishikawa diagram)
  • Strong track record of identifying and implementing novel cell therapy manufacturing technologies
  • Experience driving productive multidisciplinary projects with Research, Analytical Development, and Manufacturing partners
  • Knowledge of analytical development including flow cytometry and cell-based assays

What you should know 

  • The base pay range for this position at commencement of employment is expected to be between $240,000 and $290,000/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.

Company

Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester.

Company info
Website
Mini-site
Sana Biotechnology
Location
188 East Blaine Street, Suite 400
Seattle, WA 98102
US

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