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Sample Coordinator, GMP Operations

4 months ago

Boston, United States HireMinds Full time

Sample Coordinator, GMP Technical Operations

Boston, MA


Our client is a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines. The ideal candidate for this role will own the end-to-end sample shipment process from CDMO sample shipment delivery to sample shipment receipt at the CTLs. This individual will resolve all shipping-related quality events and investigations.


*This is a full-time, temporary contract role with the possibility of converting to a permanent position after about 3-4 months.



Responsibilities:


  • Manage all technical operations-related shipments (i.e. Stability samples, etc.) in accordance with HilleVax standard operating procedures (SOPs), approximately 25 shipments per quarter or 100 shipments per calendar year.
  • Directly interact with shipping courier(s) (i.e. QuickSTAT, World Courrier, etc.) to place and schedule sample shipment orders
  • Directly interact with shipping courier contract manufacturing organizations for sample shipment paperwork and deliveries
  • Directly interact with shipping courier contract testing laboratories for sample shipment paperwork and sample receipt
  • Investigate shipping-related quality events and deviations working with HilleVax vendors and suppliers
  • Prior experience in GMP manufacturing, supply chain and/or shipping
  • Ability to work independently
  • Ability to technical write (SOPs, Deviations, Investigations, etc.)
  • Experience working with external manufacturing cross-functional teams is a plus (Tech Ops, QA, QC, Supply Chain, etc.)


Education, Experience & Skills:


  • Bachelor’s degree with 1-2 years GMP experience
  • Travel, Physical Demands & Work Environment:
  • Prefer Boston local candidates to be on-site 3-4 days per week
  • Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).
  • Typical office and laboratory bending, stooping, and lifting requirements.
  • Willingness to travel to various meetings or client sites, including overnight trips (up to 10%)