Manager, Clinical Supplies

MBX BiosciencesBurlington, MA
Hybrid

About The Position

MBX Biosciences is looking for a driven and experienced professional to support and optimize clinical supply chain operations supporting global clinical trials for our growing portfolio of peptide drugs. In this role you will provide knowledge of planning global clinical drug supply programs/activities including technical batch record review, clinical label design, label translation coordination, packaging and labeling, IRT implementation, distribution tracking, excursion management, returns and destruction coordination.

Requirements

  • Bachelor’s degree in an applicable discipline
  • 3-5 years’ clinical supply management or equivalent experience in the pharmaceutical biopharmaceutical industry
  • Ability to communicate effectively both orally and in writing both with internal and with external vendors and partners
  • Ability to work both independently, and in a team environment
  • Ability to work in a fast paced and dynamic environment
  • Strong working knowledge of standard business software, including MS Excel, Word, and PowerPoint
  • Strong analytical and organizational skills

Nice To Haves

  • Background in working within an IRT is a plus
  • Experience in commercial supply chain is a plus

Responsibilities

  • Manage clinical investigational product supply and cold chain logistics activities for global clinical trials, including forecasting, temperature excursion management, reconciliation, and destruction.
  • Work with CMOs and logistics providers to develop packaging and labeling schedules to ensure timely delivery of investigational product.
  • Implement and manage IRT systems.
  • Track and manage shipments across a global supply chain.
  • Coordinate cross functionally with Clinical Operations, Clinical Development, CMC, Regulatory and Quality Assurance to ensure continued supply of investigational product and meet MBX development timelines and program goals.
  • Develop Standard Operating Procedures (SOPs) and guidelines related to inventory management, distribution, transportation, disposition of returned/unused materials.
  • Proactively drive cross-functional activities. Works with other functions and external partners to manage complex projects.
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