Position Summary

This on-site position plays a crucial role in ensuring the efficient and timely production of pharmaceuticals at the Petersburg, VA site. In collaboration with stakeholders, this role will be responsible for maintaining and improving the production facility's planning and scheduling process. The Senior Production Scheduler will create and maintain the near- and longer-term production facility schedule that prioritizes critical-path production activities while identifying windows of opportunity to support other studies, protocols, and maintenance/calibration activities. The opportunity to proactively identify and resolve schedule conflicts is a key success attribute. The ideal candidate for this role is responsive and flexible, articulate and succinct, while demonstrating a strong presence across various functional teams that support the facility.

The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential sterile small-molecule and biologic injectable medications.

Essential Duties and Responsibilities

The essential functions include, but are not limited to, the following:

·     Evaluate current and future production processes to identify key workflows and dependencies.

·     Collaborate with cross-functional teams to gather requirements, facilitate and oversee a comprehensive production scheduling process that optimizes and meets production requirements and proactively resolves conflicts.

·     Assess allocation of areas, equipment, utilities, and teams to ensure the appropriate visibility is in place to facilitate adjustments as needed.

·     Optimize scheduling tools and systems to streamline the scheduling process, evaluate schedule adherence, drive continuous improvement, and improve overall efficiency.

·     Develop and maintain near-term and longer-term production schedules.

·     Run daily/weekly meetings with cross-functional staff to evaluate schedule adherence, identify root causes, and reschedule any carryover to new windows of opportunity.

·     Communicate closely with the procurement team to support the availability of required materials in stock for meeting the requirements of scheduled activities.

·     Adjust production schedules in response to changes in demand, material availability, or unforeseen disruptions.

·     Level load/work balance validation, preventive maintenance, and calibration activities in the schedule with the purpose of minimizing impact to production.

·     Maintain the process of communicating production schedules and changes to relevant stakeholders.

·     Monitor and analyze production data to identify trends and areas for improvement. Identify opportunities for process improvement and implement best practices to enhance production efficiency.

·     Prepare regular reports on production schedule adherence and ensure accessibility to key stakeholders.

Minimum Qualifications (Knowledge, Skills, and Abilities)

·     Bachelor’s degree in a related field.

·     A minimum of six plus years of experience in production scheduling in the pharmaceutical/biotech or other regulated production environment.

·     Demonstrated ability to identify and address scheduling challenges in fast-paced production environments.

·     Detail-oriented with a focus on accuracy in creating and updating production schedules in real time.

·     Proficiency in using scheduling software such as Smartsheet or MS Project is preferred.

·     A working knowledge of pharmaceutical manufacturing processes, regulatory requirements, and current Good Manufacturing Practices (cGMP) is preferred.

·     Strong Excel skills and proficiency in Microsoft Office suite.

·     Strong communication and collaboration skills.

Physical Demands and Work Environment

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or listen. The employee is frequently required to use hands or fingers and handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk, sit, and reach with hands and arms. Furthermore, the employee must be able to meet aseptic gowning requirements, procedures, and certification. The employee must occasionally lift and/or move up to 25 pounds.  The noise level in the work environment is usually low to moderate.