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JOB SUMMARY

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

• Stationary Position: 3/4 of the day and up.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception
• Ability to focus ☒ No Special Vision Requirements

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 made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.

The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Minimum High School Diploma
• 7-10 years of experience in a GMPs environment required
• 4+ years of experience leading direct reports or teams is required
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred

• Bachelor’s Degree in related science field preferred
• Ability to effectively present information to various people as the job requires.
• Ability to display excellent time management skills.
• Ability to display a willingness to make decisions.
• Ability to work independently and/or part of a team.