Manager, Clinical Planning and Logistics

This is what you will do:

• The Manager, Clinical Logistics is a cross-functional key contributor that is accountable for Alexion’s small molecule, biologics, Drug Product, Finished Product and shipment/storage logistics. Responsibilities include but are not limited to leading a cross-functional team within the Alexion clinical network, Clinical Manufacturing Management to drive on time execution of manufacturing and program timelines.

You will be responsible for:

• Logistics and Warehouse Management
• Partner with Leadership to refine the division strategy and shape a balanced portfolio from a shipment perspective
• Responsible for directing all activities in logistical support of the clinical study DS/DP/FP shipments,  inventory, storage, distribution and recovery of  QA paperwork in order for release
• Evaluate current and future domestic and global shipments and evaluate other vendors for Logistic continuity and new capabilities
• Ensures timely delivery of quality clinical supplies for all assigned compounds and protocols by collaborating with internal and external sources while taking into account country Regulatory requirements
• Manages conflicts/issues with internal and external partners and stakeholders
• Coordinate cGMP cold chain shipments of clinical cell banks, Drug Substance, Drug Product, and Finished Product to supply depots for internally and externally manufactured products.
• Establish and track KPI metrics to evaluate internal and external logistics performance and review monthly with senior leadership
• SAP: Inventory management, production planning, and capacity evaluations.

You will need to have:

• More than 8 years of experience cGMP manufacturing and/or cGMP supply chain logistics
• Proficient knowledge of import / export requirements
• FDA and Customs paperwork experience
• Knowledge of cGMP and other regulatory requirements
• Knowledge in Cold Chain Logistics
• Excellent planning, organizational, analytical and management skills
• Strong attention to detail, ability to work with autonomy, and able to communicate clearly to senior management
• Proficiency with personal computers and Microsoft Office Products, including Word, Project, Power Point, Access and Excel
• Bachelor’s degree or MBA

We would prefer for you to have:

• Strong project management, presentation, communication, and negotiation skills
• Demonstrate proactive approach to identifying and mitigating risks
• Forward-thinking and strategic approach to managing projects with the ability to assess the impact of cross-functional issues and to develop a mitigation plan with appropriate level of stakeholder buy-in

• Technical acumen and experience with SAP
• The duties of this role are generally conducted in an office environment.  As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
• Knowledge of SAP transactions, inventory management, and maintenance of Master Data.