Supervisor I, Manufacturing

Job Description

As the department’s first line leader, the Production Supervisor is responsible for leading and coordinating daily manufacturing operations within aseptic or other processing areas to ensure the safe, efficient, and compliant production of sterile pharmaceutical products. This role provides direct supervision and mentorship to production staff, fostering a culture of accountability, collaboration, and continuous improvement. The Supervisor ensures strict adherence to cGMP, SOPs, and regulatory standards, while driving operational excellence and maintaining a high-performance team environment to ensure success of department goals.

Operational Leadership

• Supervise daily activities of production technicians in manufacturing, ensuring adherence to SOPs, batch records, and regulatory requirements.
• Collaborate with Specialists to create optimized hourly production schedule, room and equipment schedules, and ensure availability of critical materials and equipment.
• Monitor production schedules and adjust staffing / workflow to meet output targets and minimize downtime.
• Maintain proper gowning, aseptic techniques, and compliance in cleanroom operations.
• Ensure the team is achieving the defined KPI and everyone is aware of the goals.
• Ensure your respective team has what they need to be successful and step in where needed.
• Optimize the labor and materials associated with your respective process.

Team Development, Training & Performance

• Provide coaching, mentorship, and performance feedback to production technicians.
• Promote a culture of accountability, teamwork, and continuous improvement recognizing individual achievements and addressing performance gaps through constructive feedback and disciplinary action, if required.
• Mentor and develop Specialists and technicians while building a high-performing, engaged, and compliant workforce.
• Facilitate onboarding and ongoing training programs in sterile techniques, equipment operation, and safety.

Documentation & Reporting

• Review and approve batch records, logbooks, and other production documentation.
• Audit and maintain accurate records of production metrics, personnel, and pass downs.
• Report operational status, issues, and improvement opportunities to management.
• Update documents as needed to improve area.

Compliance & Quality Assurance

• Maintain strict compliance with FDA, EU, and other applicable regulatory standards.
• Create a culture of quality with right first-time mindset and approach.
• Support routine audits and inspections to ensure documentation accuracy and process integrity.
• Support investigations and CAPAs related to deviations, non-conformances, and quality events.
• Collaborate with QA and Manufacturing Compliance teams to ensure timely QMS closure and batch release.

Safety & Facility Management

• Ensure adherence to EHS policies and procedures, including incident reporting and hazard mitigation.
• Participate in safety audits and lead corrective actions as needed.
• Oversee cleanliness, organization, and readiness of production areas and equipment.
• Strive for zero injuries and promote a safety-first mentality.