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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