Manager, Planning & Scheduling- 1st Shift; Onsite

Job Description Job Summary

We are seeking a dedicated employee to support Global Clinical Supplies Operations at our West Point, PA facility. The Manager within Clinical Packaging Operations is responsible for providing direction and oversight to clinical packaging technicians (CPTs) that execute primary and secondary packaging in support of our clinical pipeline. In Global Clinical Supply, we are partnering across our internal packaging facilities, external contract manufacturers and suppliers to create an interdependent global manufacturing network committed to deliver a compliant, reliable supply of clinical finished goods to clinical sites and patients on time, every time, across the globe.

The individual is expected to embody enterprise leadership skills to coach the shop floor and enable the execution of packaging completion to meet the West Point Packaging, Clinical Supply Operations (CSO) and Global Clinical Supply (GCS) strategic priorities. The manager maintains compliance and ensures execution excellence through making problems visible, removing obstacles and installing the right solutions to enable reliable supply.

This role partners with the shopfloor specialists to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements. The qualified candidate must demonstrate strong critical thinking and scientific acumen to assist with troubleshooting of processes and systems. Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required.

• Directly leads activities in the packaging IPT. This requires shopfloor presence and gowning.
• Coordinates and directs a team of clinical packaging technicians
• Micro level scheduling to ensure personnel assigned to jobs as well as availability of maintenance, environmental monitoring and other scheduling needs directly pertaining to shopfloor execution
• Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Escalate compliance and product quality concerns within packaging and coordinate with quality to resolve.
• Responsible for hiring and ensuring personnel are trained and performing per expectations.
• Manage and coach the team (direct and indirect reports) to deliver strong results while developing individual and team capabilities. Provide feedback to functional service providers (FSPs) for their staff performance.
• Acquire and maintain technical process knowledge relevant to operations. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations.
• Proactively identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, increasing utilization and efficiency, improving safety and eliminate waste, while maintaining compliance.
• Review and approve production orders, standard operating procedures (SOPs) and other shopfloor centric documentation.
• Ability to serve as a subject matter expert to support quality risk assessment and other quality management system support

• Bachelor's Degree in Science, Engineering, or another technical field-with four (4) or more years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain within pharmaceutical manufacturing OR-
• Associate's degree in science,…