Job Location : Circle Pines,MN, USA
The Role:
The Supply & Logistics team, which manages inventory and distribution of starting materials, intermediates and final product for the company and GMP operations, is looking for a capable and highly motivated member to manage operational functions and handle compliance projects for the Supply & Logistics function. This is an excellent opportunity to contribute to the therapies being developed for cancer patients that are being tested in clinical studies.
In the Role You Will:
* Responsible for the physical and administrative tasks for inventory management of starting materials, intermediates, final product and test samples in support of GMP operations.
* Receipt and inventory management of materials and product in a timely manner ensuring careful handling of critical and temperature sensitive materials.
* Coordinate the timely and efficient movement and shipment of materials and product for GMP purposes and in compliance with IATA and 49 CFR DOT regulations.
* Process the receipts, movement, status change, issuance and storage of inventory via SOPs, inventory tracking systems and an ERP system.
* Support the document planning, packaging, shipping and distribution of inventory to internal departments, test labs, clinical sites, customers and vendors for both domestic and international shipments.
* Arrange R&D, equipment, samples and administrative shipments for Agenus Lexington, Agenus UK and Agenus Subsidiaries.
* Support international release documentation requirements for compliance with import and export regulations.
* Interface with vendors/customers for shipments regarding scheduling, packaging labeling, documentation and customs clearance per regulations/requirements.
* Ensure security and accountability of materials and product inventory, assist with validation of temperature-controlled storage units and perform routine cycle counting to support compliance.
* In-bounding, set-up, preventative maintenance and management of equipment assets for the Supply & Logistics department.
* Monitoring of temperature storage equipment on and off-shift and responding to alarm events.
* Perform responsibilities according to procedure and training while maintaining strict compliance to SOPs and in accordance with cGMP. Revise SOPs to be in-line with day-to-day operations and originate new SOPs for department.
* Manage Iron Mountain users, storage requirements and pickup requests.
* Manage accounts/permits/agreements/brokers and logistics couriers for Agenus operations.
* Support for daily receiving responsibilities
Qualifications: About You
* Associates degree or equivalent experience with 2+ years' experience in shipping, receiving and inventory management of materials/products in a regulated environment.
* Knowledge of GXP processes is preferred.
* Training in IATA and 49 CFR DOT regulations.
* Organized, detail oriented, able to multi-task and follow through to completion of tasks.
* Knowledge of GXP processes.
* Experience with SOP following and writing preferred.
* Experience with international import and export documentation and regulations.
* Ability to work individually, as part of a team in addition to interacting with internal and external customers/vendors.
* Proficient in Microsoft Office, Word and Excel.
* Ability to choose couriers, complete documentation and work with scientist to meet desired shipment deadlines while being cost effective.
* Ability to clearly communicate and understand team goals, as well as predict needs before they arise.
* Ability to prioritize and take ownership of multiple projects.
* Ability to operate in a continuously changing environment.
* Ability to work to push projects along and continuously look for process improvements.
* Ability to manage vendors, permits and training for the related department needs.
* Ability to manage junior team members.
* Critical competencies for the role include:
* Compliance Focused: following and building a GMP system.
* Detail Oriented: Able to pay close attention to a task, remain focused and attend to all aspects of a task.
* Collaborative: Able to work effectively as a contributing member within a team and across the company.
* Organized: Effectively prioritize and take ownership of multiple projects.
* Process & Priority Minded: Further develop capabilities for the department, team members and company with the aim to meet short and long-term program goals.
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