Senior Supply Chain Specialist

3 weeks ago

Boston, United States Biotechnology Company (Boston Area) Full time

Supply Chain Specialist/ Sr. Supply Chain Specialist

Boston/Cambridge, MA


We are a small biotech focused on developing therapies for patients. Learn more by applying and join us in our pursuit to advance clinical trials.


We are seeking a Supply Chain Associate that support interface with external parties for supply chain needs and manage activities across the supply chain lifecycle, including packaging, labeling, shipment, inventory management, and drug return logistical activities. The Associate will support the technical operations team in achieving clinical supply goals and ensuring timely, efficient, and accurate execution of any supply chain needs. We are a heavily Phase 1 / 2 focused company and the Associate will work with development teams such as clinical operations, CMC, and clinical development to meet supply needs. As we grow, documentation and strengthening of process will encompass the role as well as participating in project teams. We are ideally looking for a strong GXP (CGMP/CGCP) background with experience in documentation and logistics for clinical and other supply. The role will collaborate heavily with other manufacturing team members to optimize SOPs and adapt supply needs as need for clinical trial management.


Responsibilities:

  • with internal and external customers and suppliers to accomplish project objectives including packaging, labeling, shipment, inventory management, and drug return logistical activities
  • and maintain IMP distribution and returns drug plans and manages Clinical Supply documentation associated with assigned program, in compliance with GMP and industry standards
  • inventory levels and provide feedback to Program leads and their direct Manager regarding expiry and re-supply needs across inventory.
  • required participates in IWRS system enhancement initiatives, as assigned and needed
  • with other manufacturing peers and clinical development function to ensure clinical supply needs are met across the lifecycle
  • seek gaps in supply chain management to ensure superb clinical trial execution
  • and grow with the company and pipeline helping grow and maintain SOPs and processes to oversee vendors and inventory
  • hands-on with the Head of Supply Chain to coordinate communication with project teams and external parties
  • actively and align with Clinical Operation/Study team to help create forecast for assigned study and program including enrollment rate.
  • country logistics for shipping and importation, on assigned study or program.
  • regularly drug expiry, and the appropriate inventory levels across assigned clinical programs.
  • and oversight of packaging requirements for programs and/or protocols assigned
  • enrollment, drop-out rates and actual supply need on assigned protocols and/or programs.
  • continuous re-assessment of Project needs, on assigned programs and/or protocols.
  • label creation and approvals process, including translations for all countries, on assigned study and/or program responsible for.
  • return and destruction of IMPs from sites to depots for assigned study.
  • with other members of the Clinical Supply Chain to provide and obtain information and to ensure on time delivery of assigned study.
  • inventory checks and manage inventory levels and cycle count at the vendor yearly on assigned study
  • temperature excursions during transportation on assigned study


Requirements:

  • Bachelor's in scientific or supply chain or related field with 2+ years of relevant experience, preferably in an industry setting
  • Experience with GCP and GMP requirements is ideal. Understanding of clinical trials and drug development to support supply chain activities is preferred.
  • Experience in inventory management or supply chain management for drug supply preferred.
  • Excellent working knowledge of Microsoft Project, Power Point, MS Project, Excel, and Microsoft Office. Advanced Microsoft Excel skills required.
  • Great attention to detail and ability to manage time while working virtually.
  • Analytical thinking, fast learner with the ability to quickly grasp new concepts
  • An analytical and can-do mindset to address technical supply challenges and implement solutions
  • Work integrity and ethics suitable for working at startup environment which requires acquiring new skills, managing multiple tasks, and a can-do attitude.
  • Occasional travel may be required

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