Sr. Manager Logistics & Cold Chain Management Alnylam – Cambridge, MA, USA
The Senior Manager of Logistics and Cold Chain Management will develop and lead the logistics and cold chain operation processes for the Technical Operation Organization including developing, mapping out and implementing all distribution requirements to support of internal and external manufacturing operations. Along with the distribution network, this position will also be responsible for developing and maintaining cold chain management associated with all the distribution activities to ensure efficient flow of associated material and information throughout the commercial supply chain.
The senior manager of logistics and cold chain is responsible for supporting logistics activities of DS, BDP and DP IMP and FG throughout the Alnylam supply chain. This includes working with third party logistics across the world to ensure movement of product through customs anywhere in the world while ensuring Global Tread Compliance (GTC) including an understanding of VAT in the EU, Tax and duty as well as proper pricing of Alnylam clinical and commercial products.
She/He will help develop and implement an overall cold chain strategy for Alnylam commercial DS, BDP, DP, and FG ensuring the integrity of our products. The function will oversee the development of shipping containers capable of keeping our products and intermediates at the proper temperature. In addition, the Senior Manager of Logistics and Cold Chain Management will ensure that Alnylam shipping lanes are qualified.
Summary of Key Responsibilities: Summary of key experiences:
- Develops and implements regional distribution strategies to achieve high service levels and optimal inventory placement. Ensures that all distribution work is performed in an efficient, profitable, safe and productive manner and in adherence to company policies, local, state, federal and international laws.
- Evaluate distribution network design and develop strategies to optimize footprint requirements while maximizing delivery service.
- Establish shipping lanes for transportation of cold chain product; including managing movement of DS, DP and FDP between internal and external partners including both US and EU.
- Support the development and execution of all associated validation work to ensure a compliant and robust shipping process including cold chain qualification and validation activities.
- Responsible for investigation of any shipping and/or cold chain deviations and CAPA implementation in a timely compliant manner.
- Work to establish global alignment throughout all logistics functions including temperature controlled shipping
- Support development and maintain distribution, transportation and cold chain budgets
- Collaborate with sourcing team to handle contract and price negotiations with transport and cold chain providers
- Ensures the provision of quality supply services in terms of service, delivery, efficiency, cost effectiveness and professionalism.
- Liaises with key stakeholders to ensure the support services for Manufacturing, Quality Assurance and Commercial stays at the forefront of supply initiatives and programs.
- Ensures compliance with industrial and policy standards of logistics and cold chain technologies and services.
- Build and grow relationships with cross functional departments including Supply and Operations demand planning, manufacturing, quality, commercial, and finance as well as external stakeholders to ensure alignment and business optimization.
- Build and maintain strong collaborative relationships to ensure supply chain visions are aligned and best practices are implemented
- Participate in vendor audits and evaluation for quality of product and timely delivery
- Analyze supply chain risks and opportunities and develop business continuity plans with suppliers
- Responsible for investigation of deviations and CAPA implementation in a timely compliant manner.
- identify areas of best practices for all inter-related activities within distribution network which will optimize the efficiency of the total distribution process
- Establish commercial Cold Chain Management operations for commercial products. Including design of cold chain shipment (active & passive); qualification activities to support shipment process;
- Execute Risk Program to support risk based decision making associated with cold chain distribution
- Evaluate Existing procedures and department SOPs along with identification of gaps; modify the existing and create new procedures that align with ongoing business transformation
- Develop and implement Key Performance Indicators to support Distribution and Cold Chain Management
- Define department work priorities and at times may be involved in the complexities of day-to-day operations.
- Proactively identify and resolve customer service and supply chain issues.
- Experience in designing effective and efficient distribution networks.
- Determines passive/active container solutions in accordance to product temperature profile and considers external factors during transportation and storage (handling, storage conditions, transportation, ambient, transit time, KPI, etc.).
- Develops and implements cold chain solutions in compliance with local and Global regulatory requirements.
- Knowledge of cold chain requirements FDA (21CFR), EMEA, PDMA, cGMP, HazMat and impact on operations.