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

Candel Therapeutics

Needham (MA)

Hybrid

USD 184,000 - 200,000

Full time

14 days+

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Job summary

Candel Therapeutics, Needham MA, is hiring an Associate Director, Supply Chain – Logistics, Packaging & Shipping Validation. Hybrid work arrangement with a salary of $184,000 - $200,000.

The role focuses on end-to-end pharmaceutical supply chain operations, packaging validation, and cold chain logistics to ensure compliant storage, packaging, distribution, and shipment of clinical and commercial products. The AD will collaborate across QA, Manufacturing, Regulatory Affairs, and external

Qualifications

Bachelor's degree in Supply Chain, Logistics, Engineering, Life Sciences or related field.
5+ years pharmaceutical/regulated healthcare supply chain experience (Senior Manager) or 8+ years (AD).
Experience with packaging qualification and shipping validation programs.
Knowledge of GMP, GDP, temperature-controlled logistics, and distribution requirements.
Experience developing validation protocols, risk assessments and qualification reports.

Responsibilities

Lead end-to-end pharmaceutical supply chain activities for clinical and commercial products, including packaging operations.
Coordinate packaging, labeling, warehousing, inventory management, and distribution.
Oversee domestic and international shipments with import/export documentation and regulatory compliance.
Partner with CMOs, depots, 3PLs, CROs and transport providers to ensure service and continuity.
Develop supply chain metrics, dashboards, forecasts and inventory plans.
Lead shipping validation studies for ambient, refrigerated, frozen and ultra-low temp products.
Maintain shipping validation programs and periodic requalification.

Skills

Pharmaceutical supply chain

Packaging qualification

Shipping validation

Cold chain logistics

Cross-functional collaboration

Education

Bachelor's degree in related field

Tools

Microsoft Office

SCM systems

Job description

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

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

Why WorkWithUs? 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’san exciting time to join us and help bring transformative cancer treatments to patients. Learn more: www.candeltx.com

Position Summary

The Senior Supply Chain Manager/Associate Director (AD) is responsible for leading and supporting pharmaceutical supply chain operations with a strong focus on packaging, transportation, cold chain, and shipping validation activities. This role ensures the compliant storage, packaging, distribution, and shipment of clinical and commercial pharmaceutical products while maintaining adherence to cGMP, GDP, regulatory requirements, and company quality standards.

The position serves as a cross-functional partner to Quality Assurance, Manufacturing, Regulatory Affairs, Clinical Operations, and external service providers to ensure validated supply chain processes that protect product quality and patient safety throughout the distribution network.

Key Responsibilities

Supply Chain Operations

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.

Packaging and Shipping Validation

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.

Quality and Compliance

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.

Vendor and Logistics Management

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.

Required Qualifications

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.

Preferred Qualifications

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.