Senior Supply Chain Manager

Digital Prospectors - Cambridge, MA

Full-time - Senior

Cambridge, MA

501-1,000 employees

Professional, Scientific, and Technical Services

About the position

Our client is seeking a highly skilled Senior Supply Chain Manager to oversee the strategic management of Investigational Product (IP) supply and commercial supply chain activities. This pivotal role involves meticulous planning and coordination to ensure the seamless flow of IP from production through to distribution, while adhering to regulatory requirements and meeting demands. The ideal candidate will demonstrate exceptional leadership in cross-functional team environments and possess extensive experience in clinical supply management and vendor oversight. The Senior Supply Chain Manager will manage and coordinate packaging, labeling, storage, and distribution vendors, ensuring compliance with regulatory standards. This role requires collaboration with Clinical Operations, Clinical Supply Chain, and Technical Operations to develop packaging strategies, timelines, and budgets for clinical trials. The manager will also plan and coordinate vendor activities for label and packaging design, packaging campaigns, and label production, ensuring timely execution. In addition, the Senior Supply Chain Manager will facilitate the design, review, and approval of IP labels to meet regulatory requirements across different countries. Monitoring inventory levels across trial sites and depots is crucial, as is taking proactive measures to prevent supply issues. The manager will maintain accurate records of IP inventory, including consumption, movements, lot information, and expiry, and ensure timely review and approval of batch records for packaging and labeling activities in collaboration with Quality Assurance. Collaboration with Interactive Response Technology (IRT) vendors and distribution partners to develop specifications and conduct user testing is also a key responsibility. The manager will manage and investigate temperature excursions and product complaints from sites and depots, coordinate expiration date extensions and re-labeling operations to support ongoing clinical trial activities, and coordinate shipping validation activities and other logistical operations as required.

Responsibilities

• Manage and coordinate packaging, labeling, storage, and distribution vendors, ensuring compliance with regulatory standards.
• Collaborate with Clinical Operations, Clinical Supply Chain, and Technical Operations to develop packaging strategies, timelines, and budgets for clinical trials.
• Plan and coordinate vendor activities for label and packaging design, packaging campaigns, and label production, ensuring timely execution.
• Facilitate the design, review, and approval of IP labels to meet regulatory requirements across different countries.
• Monitor inventory levels across trial sites and depots, taking proactive measures to prevent supply issues.
• Maintain accurate records of IP inventory, including consumption, movements, lot information, and expiry.
• Ensure timely review and approval of batch records for packaging and labeling activities in collaboration with Quality Assurance.
• Collaborate with Interactive Response Technology (IRT) vendors and distribution partners to develop specifications and conduct user testing.
• Manage and investigate temperature excursions and product complaints from sites and depots.
• Coordinate expiration date extensions and re-labeling operations to support ongoing clinical trial activities.
• Coordinate shipping validation activities and other logistical operations as required.

Requirements

• Bachelor's degree or higher in Health or Life Sciences is preferred.
• Minimum of 5 to 10 years of direct experience in clinical supply management, including planning, forecasting, labeling, packaging, storage, distribution, reconciliation, returns, and destruction.
• Proven experience in managing third-party clinical supply vendors and QP releases.
• Expertise in managing clinical study demands across early and late-phase programs.
• Demonstrated knowledge of GMP batch record development, review, approval, and release processes.
• Strong understanding of warehousing, distribution, and logistics, including cold chain distribution.
• Proficient in Microsoft Office Suite, particularly Excel and PowerPoint.

Benefits

• Medical
• Dental
• Vision
• Life
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Paid Time Off (PTO)