Manager, International Logistics Engineering
vor 1 Woche
**The Role**:
In this role, the Manager of Logistics Engineering will ensure development, deployment, monitoring, governance and continual improvement of cold chain, shipping validation and secondary distribution requirements across the Moderna International organization. Ensure that Moderna pre-clinical, clinical, and commercial products complies with relevant cold chain and GDP best practices, guidance, and regulations. Assist in the deployment of end-to-end cold chain and distribution procedures and guidelines that will assure compliance and meet business needs. Act as a key knowledge point for cold chain requests, issues, lead training, and be responsible for monitoring and reporting KPIs/metrics to senior management across the Moderna International organization. Maintains and evaluates cold chain status in partnership with internal and external stakeholders/customers.
**Here’s What You’ll Do**:
Deploy, enhance, maintain, and oversee implementation of Moderna’s International Logistics Engineering program, strategy, requirements, and milestones. Act as a core member for Moderna’s Cold Chain cross functional team.
Act as an owner for Moderna International’s global shipping systems and methods, and key member of the Shipping Validation Team.
Author SOP’s Work Instructions, Policies and other documentation related to Cold Chain and distribution
Provide expert advice to Moderna’s various business units and staff on the handling, storage, and shipping of cold chain products according to current best practices, guidelines, and regulations.
Liaise with internal and external stakeholders such as Manufacturing, Distribution/Logistics, and Quality to support new shipping system implementation activities across the Moderna International organization
Support technical transfer Distribution and Cold Chain operations at CMO and 3PL sites including the handling, storage, and shipping of cold chain products.
Provide training on cold chain best practices, guidelines, and regulations across departments.
Liaise with critical stakeholders to ensure cold chain requirements are engrained in business operations.
Interact and liaise with External Quality for the qualification of vendors and service providers such as Freight Forwarders, Carriers, etc. including developing of Standard Operational Procedures (SOP), Quality Agreements and SOWs.
Maintain current knowledge of relevant cold chain requirements and monitor emerging industry trends to determine potential impacts on Moderna to ensure that our practices, guideline, and procedures remain compliant and up to date.
Support internal investigations and implement corrective actions related to non-conformities of cold chain compliance.
Support Moderna’s mission and core values.
**Here’s What You’ll Bring to the Table**:
**Education**: University degree in technology, engineering, or related field.
**Experience**: 6 (BA/BS) or 3 (MS) in various Cold Chain, Supply Chain, Manufacturing & Science, and Logistics functions (strong preference towards Pharmaceutical and Biotech experience. Experience working in a cGMP environment).
Experience and proficient knowledge of project management, risk management methodologies and monitoring techniques.
Experience with managing Quality System events (Change Controls, CAPA’s, Deviations, etc)
Experience with creating GMP Documentation (SOP’s, Work Instructions, Policies, etc)
Experience and knowledge of cold chain technology, tools, and shipping qualification.
Other government agency regulatory experience relating to biotech manufacturing.
APICS CSCP or CLTD certified preferred.
Outstanding communication skills (verbal and written) to collaborate with senior CMC Management in a dynamic, cross-functional matrix environment - you are outgoing, communicative, and seek to build relationships on a daily basis.
Well organized - a natural ability to be organized in how you think, communicate, and conduct your work.
You drive for results - you set a high bar for yourself and others. You love what you do, and it shows.
Good power point skills to visualize complex content in an easy to view manner would be a big plus.
Ability to manage projects in a fast-paced environment.
A curious mindset that allows you to constantly learn and challenge the status quo.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specifi
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