Role Summary
The Product Shipment Supervisor oversees the day-to-day operations of a team responsible for packaging, labeling, and documenting product shipments, as well as managing inventory control. This role ensures that orders are accurately processed, compliant with company and regulatory standards, and delivered on time while maintaining compliance with cGMPs and applicable regulatory requirements. This is a site-based position requiring on-site presence three days per week.
Responsibilities
- Oversees daily operations and schedules for the team handling product packaging, labeling, and shipment.
- Facilitates clear concise communication between team members, management, and external groups.
- Ensures that operations are performed per established SOPs and the collection and maintenance of data are performed in accordance with cGMPs, company standards and policies, and other regulatory requirements.
- Develops training materials and oversees team member training.
- Collaborates with manufacturing leadership team to progress cross-training and operational excellence initiatives.
- Develops meaningful metrics used to manage operational performance; identifies leading indicators that may result in process improvements or efficiency of operations.
- Ensures a safe working environment and a staff trained in safety consciousness, working with hazardous radioactive materials.
- Has strong understanding of ERP systems for managing inventory and ensuring supplies and raw materials are available for critical processes.
- Executes all phases of the performance review process, including individual goal setting and performance reviews.
- Manages performance and provides coaching, mentoring, and development of staff; effectively manages employee performance issues and corrective actions.
- Participates in continuous review/upgrade of product shipment/logistics functions to achieve a high performing, efficient, and flexible work environment.
- Interacts with external regulatory inspectors from FDA, EMEA, DOT, NRC, etc., and internal compliance auditors during in-plant inspections; ensures timely completion of corrective and preventive actions (CAPA).
- Provides a strong Quality commitment by maintaining a thorough knowledge of current and emerging US and International guidelines (FDA, DOT, IATA, cGMP).
- Writing and reviewing of investigational reports, SOPs, and the timely resolution and tracking of Quality Events (deviations, investigations, CAPAs).
- Tracks departmental spend and manages internal budgets; adheres to company policies and guidelines; exercises good judgment when incurring expenses.
- Actively demonstrates the Lantheus values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety.
Qualifications
- Required: Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent.
- Required: 2 years of experience leading operational personnel in routine or project settings with B.S., 5 years with no Bachelorβs degree.
- Required: Minimum of 2 years of experience in a regulated manufacturing environment.
- Required: A combination of education, training, and experience may be considered in lieu of above stated requirements.
- Preferred: Must have a broad knowledge of cGMPs and applicable regulatory compliance requirements.
- Preferred: Must possess excellent interpersonal skills and ability to work in a team environment, and be able to collaborate with all levels of management.
- Preferred: Must be detail oriented with the ability to multitask.
- Preferred: Ability to lead and direct work of others as well as ability to respond to changing priorities.
- Preferred: Routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays and, even in adverse weather conditions. See Essential Personnel Policy.
- Preferred: Demonstrates a detailed understanding of ERP/MRP and inventory control systems and processes.
- Preferred: Understands the importance of timely cycle counts and accurate inventory transactions in the realm of the operations and how they affect the Manufacturing/Supply Chain success.
Skills
- Strong understanding of ERP/MRP and inventory control systems and processes.
- Experience with ERP systems and data management to ensure materials are available for critical processes.
- Excellent interpersonal skills and ability to collaborate with all levels of management.
- Detail-oriented with the ability to multitask.
- Ability to lead and direct work of others and respond to changing priorities.
- Knowledge of cGMPs and applicable regulatory compliance requirements.
- Writing and reviewing investigational reports, SOPs, and tracking of Quality Events (deviations, investigations, CAPAs).
- Development and delivery of training materials and training programs.
- Data-driven decision making and development of meaningful metrics to manage operational performance.