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Senior Specialist, Logistics Engineering

Moderna
Full-time
Remote friendly (Baltimore County, MD)
United States
Operations

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Role Summary

Senior Specialist, Logistics Engineering at Moderna. Responsible for ensuring global cold chain logistics and shipping validation systems are compliant, efficient, and continuously improving. Own development and deployment of critical distribution procedures, act as a subject matter expert, and oversee Moderna's global shipping systems. Integrate technologies like IoT analytics and digital twins to enhance digital logistics innovation and support safe delivery of medicines worldwide.

Responsibilities

  • Oversee the global implementation of Moderna’s International Logistics Engineering program, including strategies, milestones, and compliance with cold chain requirements.
  • Act as owner and subject matter expert for Moderna’s global shipping systems and methods, actively contributing as a core member of the Cold Chain and Shipping Validation teams.
  • Lead projects related to logistics visibility, such as real-time tracking, temperature control, digital twins, and IoT analytics.
  • Author and manage critical documentation, including SOPs, work instructions, and policies related to Cold Chain and global distribution.
  • Partner with internal teams (Manufacturing, Distribution/Logistics, Quality) and external stakeholders to support and implement shipping systems across the International organization.
  • Train teams across functions on cold chain regulations, best practices, and guidelines to embed compliance culture across the organization.
  • Support the distribution-related technical transfer activities at CMO and 3PL sites.

Responsibilities Will Also Include

  • Provide guidance during GMP/GDP audits and regulatory inspections concerning cold chain and logistics engineering.
  • Monitor, assess, and develop controls to ensure compliance with cold chain handling, storage, and shipping across the supply chain.
  • Qualify and collaborate with external vendors such as Freight Forwarders and Carriers, contributing to SOP development, Quality Agreements, and Statements of Work.
  • Stay abreast of evolving cold chain regulations and trends, ensuring Moderna’s guidelines remain best-in-class and fully compliant.
  • Support internal investigations and drive corrective actions related to any non-conformities in cold chain operations.
  • Report key performance indicators (KPIs) and risk metrics to senior leadership to drive continuous improvement in cold chain performance.
  • Perform additional duties as required in alignment with evolving business and compliance needs.

Skills

  • Experience with cold chain technology, tools, and shipping qualification.
  • Experience with IoT devices, digital twins, AI tools and their application.
  • Experience with managing Quality System events (Change Controls, CAPAs, Deviations, etc).
  • Outstanding communication skills (verbal and written) to collaborate with senior management in a dynamic, cross-functional matrix environment.
  • Well organized with strong project management and organizational abilities.
  • Ability to drive for results and work in a fast-paced environment.
  • Ability to visualize complex content and create clear presentations.
  • A curious mindset that continuously learns and challenges the status quo.

Education

  • University degree in technology, engineering, or related field.

Qualifications

  • Required: 4–6 years (BA/BS) or 2–4 years (MS) in Cold Chain, Supply Chain, Manufacturing & Science, and Logistics functions, with preference for pharmaceutical/biotech and cGMP experience.
  • Preferred: APICS CSCP or CLTD certification; experience with IoT, digital twins, and project/risk management methodologies; experience with GMP documentation; regulatory experience in biotech manufacturing; strong communication skills; ability to manage projects in a fast-paced environment.