Full-Time

Director Apheresis Operations

Sana Biotechnology

Sana Biotechnology

201-500 employees

Engineers cells as medicines for untreatable diseases

Biotechnology

$200000 - $230000

Employee stock purchase plan

Senior, Expert

Cambridge, MA, USA + 2 more

Requirements
  • 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
  • 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
Responsibilities
  • 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

Company Stage

N/A

Total Funding

$865M

Headquarters

Seattle, Washington

Founded

2018

Growth & Insights
Headcount

6 month growth

-13%

1 year growth

-18%

2 year growth

-9%
INACTIVE