Associate Director Supply Chain

Title:   Associate Director, Supply Chain – Logistics, Packaging & Shipping Validation

Location:  Hybrid, Needham MA 
Salary: $184,000 - $200,000

Why Work With Us? At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. Like a team, we show up for each other and stay focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability, encouraging ownership and innovation every day.  

Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it’s an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com 

• Manage end-to-end pharmaceutical supply chain activities for clinical and commercial products, focused on logistic and packaging operations.
• Coordinate packaging, labeling, warehousing, inventory management, and distribution activities.
• Oversee domestic and international shipments, including import/export documentation and customs requirements.
• Partner with CMOs, depots, 3PLs, CROs and transportation providers to ensure supply continuity and service performance.
• Develop and maintain supply chain metrics, dashboards, forecasts, and inventory plans.

• Lead shipping validation studies for ambient, refrigerated, frozen, and ultra-low temperature products.
• Develop, review, and approve validation protocols, reports, risk assessments, and qualification documentation.
• Design and execute packaging qualification and transportation validation programs.
• Support lane qualification, route validation, temperature mapping, and seasonal shipping studies.
• Assess and qualify shipping systems, insulated containers, refrigerants, temperature monitoring devices, and packaging configurations.
• Evaluate shipping excursion data and implement corrective actions when needed.
• Maintain shipping validation programs in a state of continuous compliance through periodic review and requalification activities.

• Ensure compliance with GMP, GDP, FDA, EMA, ICH, USP, and applicable global distribution regulations.
• Support deviation investigations, CAPA implementation, change control, and risk management activities.
• Participate in internal audits, supplier audits, and regulatory inspections.
• Establish and maintain quality agreements with logistics providers and packaging vendors.
• Ensure all supply chain processes remain inspection-ready and properly documented.

• Manage relationships with third-party logistics providers, depots, freight forwarders, packaging vendors, and CMOs.
• Lead contractor qualification, onboarding, performance monitoring, and quality oversight activities.
• Review service metrics, implement improvements, and resolve operational issues.
• Drive continuous improvement initiatives related to transportation performance, cost optimization, packaging efficiency, and product protection.

• Bachelor's degree in Supply Chain Management, Logistics, Engineering, Life Sciences, Pharmaceutical Sciences, or related discipline.
• 5+ years (Senior Manager) or 8+ years (AD) of pharmaceutical, biotechnology, or regulated healthcare supply chain experience.
• Demonstrated experience with packaging qualification and shipping validation programs.
• Working knowledge of GMP, GDP, temperature-controlled logistics, and pharmaceutical distribution requirements.
• Experience developing and executing validation protocols, risk assessments, and qualification reports.
• Strong understanding of cold chain packaging systems, temperature monitoring technologies, and distribution risk management.
• Experience managing third-party logistics providers and contract service organizations.
• Excellent project management, communication, and organizational skills.
• Proficiency with Microsoft Office and supply chain management systems.

• Experience supporting clinical trial material supply and/or commercial product distribution.
• Hands-on experience with:
  • Shipping lane qualification
  • Seasonal shipping validation
  • Temperature mapping studies
  • Warehouse qualification
  • Cold chain packaging qualification
  • Data logger qualification and monitoring systems
• Knowledge of FDA, EMA, WHO, ICH, USP <1079>, and GDP guidance.
• PMP certification and/or APICS certification preferred.
• Experience with biologics, cell and gene therapy, vaccines, or other temperature-sensitive pharmaceutical products.

• Pharmaceutical Supply Chain Management
• Packaging Qualification
• Shipping Validation
• Cold Chain Logistics
• GDP/GMP Compliance
• Risk Assessment and Mitigation
• Deviation Investigation and CAPA
• Vendor Management
• Project Leadership
• Cross-Functional Collaboration
• Continuous Improvement
• Regulatory Inspection Readiness

• Up to 20–30% travel for site visits, audits, vendor oversight, validation activities, and business meetings.