Manufacturing

Sr. Manager, Clinical Supply Chain Direct Hire MA

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Job ID: 15925 Direct Hire MA

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Growing Gene Therapy company here in Cambridge, MA is seeking a Sr. Manager, Clinical Supply Chain to join their team!  This role be responsible for establishing the Clinical Supply function and creating the policies and procedures necessary to support clinical programs as they progress through the development pathway.  The successful candidate must be collaborative, creative, pragmatic and flexible to develop “phase appropriate” structure suitable to evolve along with the company driven by its lead programs.  Responsibilities include but not limited to:

  • Establish the supply chain function and management of time-critical clinical supply planning and execution for several gene therapy clinical programs
  • Serve as the good distribution practice (GDP) and international customs navigation subject matter expert
  • Work closely with and provide hands-on oversight to multiple third-party vendors, ensuring each link in the supply chain remains connected with the clinical sites and manufacturing operations and is compliant with quality requirements
  • Closely interact and communicate with Clinical Operations, Manufacturing, and Quality to ensure multiple handoffs in the supply chain is seamless and transparent
  • Monitor and track shipments in real time to ensure smooth transit through the logistical path –including international shipping and customs clearance
  • Create and maintain inventory and valuation tracking tools/metrics for clinical supplies
  • Provide monthly inventory and trending reports for multiple inventory locations
  • Create policies and procedures in collaboration with cross-functional leads to maintain compliance within the Clinical Supply function

Requirements:

  • BS degree with 8+ years direct experience in pharma/biotech clinical supply chain
  • Experience with complex clinical programs requiring time-critical cold-chain transport, international shipments/customs clearance
  • Experience with supply chain management for viral vector and autologous cell transport is preferred
  • Thorough understanding of regulatory requirements for clinical supply distribution in the US, APAC including Japan, and EU (including testing, labeling, and customs)
  • Demonstrated ability to oversee multiple third-party vendors globally
  • Ability to travel both domestically and internationally as needed