Manager, Supply Chain Logistics

Posted 3 Days Ago
Hiring Remotely in USA
Remote
Senior level
Biotech
The Role
Manage end-to-end cold-chain logistics and global transportation for biologics, ensuring inventory control across CMOs/CDMOs, temperature compliance, customs clearance, and carrier performance. Partner cross-functionally and with 3PLs to resolve deviations, optimize trade lanes, and maintain GxP/regulatory adherence to support clinical development programs.
Summary Generated by Built In

About Us

We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

Reporting to the Senior Director, Supply Chain, the Manager, Supply Chain Logistics will execute high-value, end-to-end cold-chain logistics for biologics, focusing heavily on APAC, EU, and US based CRO/CMO/CDMO inventory management, APAC-US, EU-US, and US-EU inbound freight forwarding, and domestic transportation. This role is responsible for global transportation of drug substance, drug product, and various sample and stability materials. This role is also responsible for maintaining tight inventory control over large molecule drug substance, drug product, and other materials and components across a fragmented external manufacturing network. The ideal candidate will anticipate and mitigate cross-border transit risks; ensure strict GxP and temperature compliance, optimize international transportation lanes, and streamline customs clearance to guarantee zero-defect product delivery.

You will build effective partnerships with key stakeholders across a range of functions, including CMC and GMP manufacturing, Analytical Development, Quality Assurance, Discovery, and external service providers, including CROs/CMOs/CDMOs, 3PLs, and freight vendors to ensure delivery of our materials to support all product programs. Additionally, you will partner with 3PLs to ensure delivery timeline adherence and resolve customs holds and delays. Prior experience with global pharmaceutical logistics and inventory management is essential to be successful in this role.

This is an exciting opportunity to make significant contributions to the evolution of Dianthus’ global supply chain strategy to support our clinical development program(s) and beyond.  We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

Inventory Management

  • Network Inventory Control: Maintain real-time visibility and reconciliation of biologics inventory and components across multiple global CMO/CDMO and storage sites.
  • Materials Synchronization: Partner with project managers to coordinate the seamless transfer of biologics materials and packaging components to prevent manufacturing downtime.

Global Transportation & Cold Chain Logistics

  • Real-time Monitoring: Implement and review data logger tracking (temperature/GPS) to ensure strict adherence to product stability requirements during transit.
  • Carrier Performance: Partner with Supply Chain leadership to provide carrier feedback, track carrier KPIs, including on-time delivery metrics.

Compliance, Customs & Quality Assurance

  • GxP & Regulatory Adherence: Ensure all logistics activities comply with cGMP, cGDP, FDA, EMA, NMPA, and local global health authority frameworks.
  • Cross-Border Customs Clearance & Brokerage: Manage international trade documentation including but not limited to commercial invoices, bills of lading, and import / export licenses.
  • US Import Requirements: Ensure strict compliance with US customs regulations, including FDA import alerts, FDA prior notice filings, and USDA guidelines for animal-derived biological materials.
  • CAPA & Deviations: Partner with providers to resolve logistics deviations, customs delays, and temperature excursions. Implement robust corrective and preventive (CAPA) plans.

Experience

  • Bachelor’s Degree in Supply Chain Management, Logistics, Business Administration, Life Sciences, or a related Life Sciences field.
  • At least 5 years of biopharmaceutical, pharmaceutical, or medical device cold-chain logistics, with a focus on biologics or large-molecule products.
  • At least 2 years of direct experience managing inbound freight forwarding from APAC and EU countries into the United States. Strong knowledge of global trade compliance and biologics import / export requirements and GxP regulations.
  • Strong knowledge of thermal packaging and temperature monitoring technology.
  • Advanced experience in Excel and basic experience utilizing ERP systems (Oracle/Oracle NetSuite, SAP, etc.), Laboratory Information Management Systems (LIMS), and Warehouse Management Systems (WMS).
  • Certifications such as Certified Supply Chain Professional (CSCP) and Certified in Logistics, Transportation and Distribution (CLTD), and/or training in IATA Dangerous Goods (for dry ice / LN2 shipments) are highly preferred.
  • Ability to translate technical logistics data cleanly to Technical Operations and Finance teams. Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
  • Skilled at evaluating complex transit data, trade lane costs, and warehouse capacity constraints.
  • Strong ability to forecast supply chain bottlenecks, geopolitical disruptions, and build robust contingency routes for high-value biological cargo.
  • Ability to effectively collaborate with APAC and EU partners across significantly different time zones.
 
 

Skills Required

  • Bachelor's degree in Supply Chain Management, Logistics, Business Administration, Life Sciences, or related field.
  • At least 5 years of biopharmaceutical, pharmaceutical, or medical device cold-chain logistics experience with biologics/large-molecule products.
  • At least 2 years direct experience managing inbound freight forwarding from APAC and EU into the United States.
  • Strong knowledge of global trade compliance and biologics import/export requirements and GxP regulations (cGMP, cGDP, FDA, EMA, NMPA).
  • Strong knowledge of thermal packaging and temperature monitoring technology, including data logger tracking (temperature/GPS).
  • Advanced experience in Excel.
  • Basic experience with ERP systems (Oracle/Oracle NetSuite, SAP), Laboratory Information Management Systems (LIMS), and Warehouse Management Systems (WMS).
  • Experience with US import requirements, FDA prior notice, import alerts, and USDA guidelines for biological materials.
  • Experience managing cross-border customs clearance, trade documentation, and brokerage.
  • Ability to resolve logistics deviations, customs delays, temperature excursions and implement CAPA.
  • Strong communication and interpersonal skills; ability to translate technical logistics data to Technical Operations and Finance.
  • Skilled at evaluating transit data, trade lane costs, and warehouse capacity; forecasting bottlenecks and building contingency routes.
  • Ability to collaborate effectively with APAC and EU partners across different time zones.
  • Certifications such as CSCP, CLTD, and/or IATA Dangerous Goods training (for dry ice/LN2 shipments).
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The Company
HQ: Waltham, MA
34 Employees

What We Do

Dianthus is a biotechnology company dedicated to designing and delivering the next generation of best-in-class monoclonal antibodies with improved selectivity and potency. Led by a multidisciplinary team of seasoned biotech entrepreneurs and scientists, we are pioneering selective antibodies of validated and emerging complement targets to allow people with rare and severe autoimmune diseases live healthier lives to their fullest potential.

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