Senior Manufacturing Supervisor M-F 4PM to 12:30 AM

Benefits

Additional Information

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Manufacturing Senior Supervisor leads a manufacturing team in a variety of complex tasks in multi-facilities in accordance with the FDA and other regulatory agencies while following all safety guidelines of PCI. They will be responsible for supervising an aseptic and medical device manufacturing team (ex., equipment preparation, filling, and Lyophilization activities). Ensure execution of production plans across multiple shifts and manage staff performance against the department's operational goals. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Ensure the safety of manufacturing area and work practices in accordance with all PCI Health, Safety, and Environmental programs. Demonstrate the ability to lead departmental safety teams on projects to drive area improvement Be a highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others Demonstrate the ability to coach less tenured supervisors and provide assistance in appropriate performance management as needed Coordinate and supervise Manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work in multiple facilities. Partner with Planning to ensure effective prioritization and schedule adherence and to meet all required capacity demands in multiple facilities. Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met Ensure audit inspection readiness of assigned manufacturing areas. Participates and takes a lead role, as needed, in inspections conducted by external clients and governmental regulatory agencies. Plan and execute manufacturing instructions in order to perform equipment preparation, and fill activities for aseptic and non-aseptic products in accordance with Good Manufacturing Practices (GMP) Lead and collaborate with the other supervisors and enabling groups to optimize processes, with specific focus on Continuous Improvement projects tied to corporate and site-specific initiatives Recruit and supervise staff to execute department functions; ensure effective utilization of resources through consistent performance management Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals, and corporate quality standards. Ability to lead the operations area in the absence of the Manufacturing Manager. Proactively identifies, evaluates, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams Create and establish key performance indicators in alignment with department goals, maintain and report applicable area or organizational metrics Collaborate with training to design department training plan and training plan execution. Ensure Training materials are accurate and sufficiently detailed Ensure Timely completion of investigations, deviations and CAPAs. Utilize quality metrics to measure, analyze, and improve team performance. Ensure real time batch review and "Right First Time" standard Proactively identifies continuous improvement opportunities to improve processes and practices Able to take lead role for department on cross-functional technical projects Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions PROFESSIONAL SKILLS Experience with GMPs, FDA and other regulated agency environments is required Experienced in making real time decisions on safety, process, scheduling and personnel-related issues. Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs Proven leadership, persuasiveness, initiative, and problem solving skills QUALITIES Attention to detail Team oriented Results driven Collaboration Adept communication skills to all levels of the organization Strong technical writing skills Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be mad

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