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DG
DSJ Global
Production Manager - Aseptic
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Job Description
A leading pharmaceutical manufacturing organization is seeking a Production Manager to support the manufacturing of sterile injectable products within a highly regulated aseptic environment. This individual will be responsible for overseeing all manufacturing activities during their assigned shift, ensuring compliance with current Good Manufacturing Practices (cGMP), maintaining production efficiency, and leading cross-functional manufacturing teams. The role will have accountability for safety, quality, production performance, employee development, and shift execution.
Key ResponsibilitiesLead and coordinate all manufacturing activities for the assigned production shift.
Ensure compliance with cGMP regulations, site procedures, and quality standards.
Manage shift operations across multiple sterile manufacturing functions, including aseptic processing, equipment preparation, filling operations, and production support activities.
Communicate production status, shift performance, and operational issues to leadership and incoming shift teams.
Serve as the primary point of contact for internal support departments during off-shift operations.
Monitor and report key performance indicators (KPIs) related to production, quality, safety, and efficiency.
Drive schedule adherence and optimize material utilization.
Lead investigations related to production deviations, quality events, and safety incidents.
Develop, mentor, and coach direct reports while supporting succession planning efforts.
Promote continuous improvement initiatives to enhance manufacturing performance and operational excellence.
Maintain training compliance and ensure team members are appropriately trained for assigned responsibilities.
Collaborate across departments and allocate resources as needed to support business objectives.
QualificationsAssociate's degree in Science, Engineering, Business, or a related discipline.5+ years of manufacturing experience within pharmaceutical, biotech, medical device, or other regulated manufacturing environments.2+ years of leadership or supervisory experience.
Strong understanding of cGMP regulations, quality systems, and manufacturing operations.
Key ResponsibilitiesLead and coordinate all manufacturing activities for the assigned production shift.
Ensure compliance with cGMP regulations, site procedures, and quality standards.
Manage shift operations across multiple sterile manufacturing functions, including aseptic processing, equipment preparation, filling operations, and production support activities.
Communicate production status, shift performance, and operational issues to leadership and incoming shift teams.
Serve as the primary point of contact for internal support departments during off-shift operations.
Monitor and report key performance indicators (KPIs) related to production, quality, safety, and efficiency.
Drive schedule adherence and optimize material utilization.
Lead investigations related to production deviations, quality events, and safety incidents.
Develop, mentor, and coach direct reports while supporting succession planning efforts.
Promote continuous improvement initiatives to enhance manufacturing performance and operational excellence.
Maintain training compliance and ensure team members are appropriately trained for assigned responsibilities.
Collaborate across departments and allocate resources as needed to support business objectives.
QualificationsAssociate's degree in Science, Engineering, Business, or a related discipline.5+ years of manufacturing experience within pharmaceutical, biotech, medical device, or other regulated manufacturing environments.2+ years of leadership or supervisory experience.
Strong understanding of cGMP regulations, quality systems, and manufacturing operations.