Supervisor Manufacturing

This position is responsible for supervision of manufacturing operations and staff associated with the manufacture of same-day release pharmaceutical products. The Manufacturing Supervisor oversees operations to ensure that safety and compliance with cGMPs (and applicable regulatory requirements) are maintained at all times. Promotes a culture of compliance, innovation, collaboration and accountability.

Key Responsibilities/Essential Functions

• Supervises day to day operations and scheduling of manufacturing personnel.
• Facilitates clear concise communication between team members, management, and external groups.
• Ensures that operations are performed per established SOP’s and the collection and maintenance of data are performed in accordance with cGMP’s, 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. Looks to identify 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 manufacturing 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. Ensure timely completion of any corrective and preventive actions (CAPA) made.
• 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.

Basic Qualifications

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is required.
• 2 years of experience leading operational personnel in routine or project settings with B.S., 5 years with no Bachelors degree.
• Minimum of 2 years of experience in a regulated manufacturing environment
• A combination of education, training, and experience may be considered in lieu of above stated requirements

Other Preferred Skills and Knowledge

• Must have a broad knowledge of cGMPs and applicable regulatory compliance requirements.
• Must possess excellent interpersonal skills and ability to work in a team environment, and be able to collaborate with all levels of management.
• Must be detail oriented with the ability to multitask.
• Ability to lead and direct work of others as well as ability to respond to changing priorities.
• Routinely scheduled work, and or overtime work required on evenings, weekends, and or holidays and, even in adverse weather conditions. See Essential Personnel Policy.
• Demonstrates a detailed understanding of MRP and inventory control systems and processes.
• 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.