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Director Apheresis Operations

Sana Biotechnology

Sana Biotechnology

Operations
Cambridge, MA, USA · Seattle, WA, USA · South San Francisco, CA, USA
Posted 6+ months ago

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 logistics coordinator, you will report to the Head of External Manufacturing to onboard and manage the apheresis centers who provide cells for Sana’s portfolio of allogeniec cell therapies. You’ll be Sana’s subject matter expert in apheresis collection and requirements. Every cell that we ultimately dose to a patient will flow through your hands. Cool stuff.

What you’ll do

  • Manage the network of cell collection facilities for Sana including sourcing, verification of capabilities, and monitoring performance
  • Coordinate among apheresis collection centers, manufacturing sites, internal stakeholders, and logistics providers to ensure seamless execution from donor selection through to manufacturing
  • Collaborate with cross-functional team including Supply Chain, PD, AD, Quality, and Research to define requirements for sustainable supply of cellular starting materials for Sana’s pipeline of hypoimmune, allogeneic CAR T programs
  • Manage the selection, on-boarding and continued performance of the apheresis centers according to program plans and strategy
  • Provide technical expertise in apheresis collection to program, portfolio, and technical strategy workstreams. Represent the department on cross-functional project teams, as requested.
  • Monitor and evaluate the quality of cell sources to ensure their suitability for use in allogeneic cell therapy production
  • Develop and maintain Sana’s apheresis playbook and any other standards and procedures associated with cell collection and donor selection
  • Provide input or draft relevant sections of global regulatory submissions and RFIs. Act as subject matter expert on topics related to apheresis collection, and donor selection
  • Define and lead overall donor cell collection network from strategic to daily management to support Research and Development and GMP needs
  • Define and build systems and tools that enable data collection and analysis in support of optimizing the efficiency and quality of donor screening and cell collection, shipping, and storage

What we’re looking for

  • Bachelor’s Degree in life sciences field with minimum 10 years of experience in a regulated environment either hospital or pharmaceutical/biotech or apheresis and/or cell therapy operations management
  • Experience working in Cell Therapy, Apheresis or Stem Cell Transplant programs essential
  • Knowledge of Apheresis collection process, characterization, instrumentation, and best practices

What will separate you from the crowd

  • Experience with logistics and scheduling between apheresis collection and GMP manufacturing
  • Knowledge of applicable regulations and standards related to Cell Therapies, Cell Collection, and Donor Requirements, including international standards for cell collection and donor requirements
  • Experience with FACT/ JACIE and ISBT accreditation procedures
  • Experience working with critical raw material suppliers or contract manufacturing organizations

What you should know

  • Domestic travel required, approximately 25% (including travel to apheresis centers and internal business meeting, as needed).
  • The base pay range for this position at commencement of employment is expected to be between $200,000 and $230,000/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.