Manufacturing Supervisor

PCI Services•Bedford, NH

31d

About The Position

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 Supervisor leads a manufacturing team in a variety of complex tasks 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 department's operational goals.

Requirements

Minimum High School Diploma
5-7 years of experience in a GMPs environment required
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

Nice To Haves

3-5 years of experience leading direct reports or teams is preferred

Responsibilities

Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.
Be highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others
Coordinate and supervise Manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work
Partner with Planning to ensure effective prioritization and schedule adherence and to meet all required capacity demands
Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met.
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)
Collaborate with the other supervisors and enabling groups to optimize processes
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
Proactively identifies, assesses, and mitigates operational and organizational risks; escalate key risks and issues to manufacturing senior management and cross-functional support teams
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"
Ensure Inspection readiness of assigned manufacturing areas. Participates in inspections conducted by external clients and regulators
Identifies continuous improvement opportunities to improve processes and practices
The supervisor will be responsible for communicating the status of all projects to their Manufacturing Manager
Interacts with cross functional support teams such as Operations, Materials Management, Engineering, MTS, R&D, Validation, QA, etc.
Responsible for directing activities of staff members
Prepare employee performance evaluations
Recommend merit increases based on performance
Must be able to observe and identify potential employees' issues and recommend/carryout disciplinary action as necessary
Collaborate with other Manufacturing Supervisors as necessary to carryout responsibilities