General Summary:
The Senior Manager of Cold Chain Logistics Process is responsible for leading the development and implementation of processes and procedures to ensure the success of cold chain logistics operations. Collaborates with logistics service providers, order management, quality assurance, packaging engineering, and other stakeholders to ensure adherence to regulatory guidelines and meet business needs. Develops a robust logistics network to support pipeline programs, evaluates and launches logistics and supply chain information systems, and manages quality systems from open to closure.
Key Duties And Responsibilities:
- Develop and implement SOPs and work instructions with global contract manufacturing organizations and logistics service providers.
- Manage quality systems, including deviations, CAPAs, and change controls, from open to closure.
- Develop a robust logistics network (supplier qualification, shipping validation, lane selection) for pipeline programs.
- Evaluate, build, and launch logistics and supply chain information systems.
- Ensure shipments are on time and compliant with Technical Operations, Trade Compliance, QA, and Supply Chain Planning.
- Define, measure, and communicate KPIs for logistics/distribution effectiveness.
- Resolve quality exceptions and complex logistical issues; select transport modes as necessary.
- Ensure compliance with Good Distribution Practices.
- Lead process redesign workshops; manage process changes and controlled documents.
- Educate business users; monitor and provide feedback on process performance.
- Coordinate SOWs and POs; assume ownership of new capabilities as required.
- Perform other duties as assigned.
Knowledge And Skills:
- Experience managing logistics for Cell and Gene Therapy programs and short lead-time cold chain operations.
- Familiarity with logistics across internal and external (CDMO) manufacturing sites.
- Strong understanding of Good Distribution Practices and Trade Compliance.
- Analytical skills; strong communication.
- Proficiency with Microsoft Excel, Word, PowerPoint, Visio, and Access; data analysis and presentation.
- ERP systems knowledge (Oracle a plus).
Education And Experience:
- Bachelorβs degree in engineering/scientific, business, or related field.
- MS in a relevant field (Engineering, Business Management, IT, Financial Management, etc.).
- Typically requires 6 years of experience (or equivalent education/experience) in logistics and distribution.