Job Description

General Summary:

The Manager, Temperature Controlled Logistics (TCL) is responsible for supporting the development, implementation, and continuous improvement of processes and procedures that enable reliable, compliant temperature-controlled logistics operations across Vertex. This role partners closely with Logistics Operations teams across all modalities, Logistics Service Providers, Quality Assurance, Packaging Engineering, Supply Chain, Technical Operations, Trade Compliance, Sourcing & Procurement, and internal and external manufacturing organizations to ensure product quality, regulatory compliance, and evolving business needs are consistently met.

The successful candidate will help design, build, and sustain a robust logistics network that supports pipeline and commercial programs. Key responsibilities include evaluating and deploying innovative active and passive packaging solutions; assessing IoT-enabled monitoring devices and temperature data loggers; and evaluating vendor systems and data capabilities to enable real-time monitoring of shipment integrity and temperature conditions. The Manager will also oversee logistics quality-system activities, including change controls, from initiation through closure.

This position requires a collaborative, data-driven leader with a strong quality and compliance mindset, deep cold-chain logistics expertise, and the ability to anticipate, troubleshoot, and resolve complex operational issues in a fast-paced environment.

Key Duties and Responsibilities:

• Develop, implement, and maintain standard operating procedures, work instructions, and packaging instructions that enable compliant logistics activities across the Global Supply Chain and Internal and External manufacturing network, in alignment with Logistics Service Providers.
• Ensure temperature-controlled logistics processes consistently support product quality, regulatory requirements, and business objectives. Serve as the primary point of contact for shipping and validation activities during Health Authority inspections and internal audits.
• Manage logistics related quality system activities, including deviations, corrective and preventive actions, after-action reviews, and associated remediation activities.
• Own the development and maintenance of Logistics Validation Master Plans supporting the validation of shipping and storage activities across modalities and product types throughout the product lifecycle, from clinical development through commercial operations.
• Partner with Product and Program Teams to support product launches, lifecycle-management activities, and evolving temperature-controlled logistics requirements.
• Support supplier qualification, transportation lane selection, risk assessments, and transportation mode decisions for temperature-controlled shipments, including the selection of qualified active and passive packaging solutions.
• Own the periodic review and maintenance of the internal Logistics Risk Assessment tool, including lane and route data, in close partnership with Logistics Operations teams and Logistics Service Providers.
• Collaborate with Logistics Operations, DTE, Quality, and other cross-functional stakeholders to evaluate, implement, launch, and continuously enhance logistics and supply chain information systems.
• Define, measure, analyze, and communicate temperature-controlled logistics key performance indicators and supporting metrics to assess logistics and distribution performance and identify improvement opportunities.
• Participate in quality exception investigations and lead the resolution of complex cold-chain and logistics issues, including implementation of remediation and preventive measures.
• Lead process redesign workshops, manage process changes, and identify opportunities to improve operational performance, compliance, and scalability.
• Facilitate cross-functional process workshops to gather requirements, align stakeholders, and translate business needs into sustainable, scalable process improvements.
• Champion change management activities by educating stakeholders and supporting business users responsible for operating logistics processes, newly implemented capabilities, and temperature-controlled solutions.
• Establish work plans and prioritize activities for external workforce resources and third party companies supporting shipping validation studies. Ensure work is delivered in accordance with internal policies and procedures, required timelines, and approved budgets.
• Support the development and coordination of statements of work for applicable subcontracted services and monitor invoices for related activities.

Knowledge and Skills:

• Bachelor’s degree in relevant discipline
• 5-7+ years progressive experience in Engineering, Quality and/or Manufacturing roles in the pharmaceutical industry – Experience with Clinical/Commercial  drug, device and/or combination products across Biologics and Genetic and Cell Therapy technologies.
• Master’s degree in business or supply chain or industrial engineering or finance preferred.
• Experience in leading development and implementation of packaging solutions used in logistics activities across complex logistics operations.
• Thought leader in Logistics, Warehousing and Transportation with a proven ability to innovate and implement practical, compliant solutions.
• Proven ability to work seamlessly across teams and develop excellent partnerships with peers.
• Demonstrated experience of the principles and regulations associated with GDP / GxP compliance.

Education and Experience:

• Direct experience managing temperature-controlled and cold-chain logistics for small-molecule, cell therapy, and gene therapy programs, including short-lead-time operations.
• Experience managing logistics across internal manufacturing sites, external manufacturing partners, and CDMOs.
• Strong knowledge of Good Distribution Practices, trade-compliance requirements, and regulations related to hazardous shipments, employee safety, and freight classifications.
• Working knowledge of logistics technology and data integrations, including Transportation Management Systems, Warehouse Management Systems, and carrier integrations.
• Strong analytical and data-driven approach to evaluating performance, identifying risks, and developing practical solutions.
• Advanced Microsoft Excel skills, including tables, arrays, formulas, and conditional formatting.
• Demonstrated ability to anticipate operational risks, develop effective contingency plans, and resolve complex logistics issues through critical thinking and creative problem-solving.
• Excellent written, verbal, interpersonal, and presentation skills, with the ability to communicate complex issues and solutions effectively across the organization.
• Proven ability to build trusted relationships, influence stakeholders, and create alignment across cross-functional teams and all organizational levels.
• Strong organizational, time-management, and prioritization skills, with the ability to work independently and effectively in a collaborative, fast-paced, and evolving environment.
• Sound business judgment, flexibility, and the ability to manage change while maintaining focus on quality, compliance, and operational performance.
• Demonstrated supervisory and resource-management capabilities, including the ability to develop team members and optimize budgets, staffing, technology, and other resources to achieve business objectives.
• Professional certifications and membership in Professional Associations (APICS CLTD, CSCP) is strongly preferred.

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.  

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

#LI-Onsite

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]