OverviewThe Filling Manager will be responsible for leading the day-to-day operations of sterile filling lines and ensuring safe, compliant, and efficient execution of manufacturing activities. This role will build, hire, train, and manage the filling operations team and provide operational leadership throughout facility start-up, commissioning, qualification, process validation, and routine GMP manufacturing.
The Senior Filling Manager will work closely with Engineering, Technical Services, Quality, Validation, and other cross-functional teams to establish operational readiness and maintain reliable, compliant manufacturing operations. The role will also provide technical and operational support for the development and maintenance of manufacturing procedures, batch records, training programs, and other GMP documentation.
This position will have direct reports and will be responsible for developing a high-performing sterile filling operations team.
ResponsibilitiesOperations Management- Lead and oversee the day-to-day operation of sterile filling lines, ensuring manufacturing activities are executed safely, efficiently, and in compliance with approved procedures and cGMP requirements.
- Develop production schedules and coordinate staffing, shift coverage, and operational resources to support facility start-up, qualification, validation, technical transfer, and routine manufacturing.
- Monitor line performance, production output, equipment utilization, and operational issues, and drive actions to improve safety, quality, efficiency, and productivity.
- Ensure appropriate line clearance, material handling, aseptic practices, gowning, and manufacturing controls are consistently followed during filling operations.
- Partner with Engineering and Maintenance to support equipment troubleshooting, preventive maintenance, changeover activities, and continuous improvement initiatives.
Regulatory Compliance- Ensure filling operations comply with cGMP requirements, internal quality standards, approved batch records, SOPs, and applicable regulatory expectations for sterile manufacturing.
- Lead or support the preparation, review, and periodic revision of SOPs, batch records, work instructions, forms, and other manufacturing documentation.
- Review completed batch records and manufacturing documentation for accuracy, completeness, and adherence to established procedures before submission to Quality.
- Support deviation investigations, CAPA implementation, change controls, and technical assessments related to filling operations.
- Support regulatory inspections, customer audits, and internal audits by representing the filling operations function and ensuring the team is inspection-ready.
- Promote and maintain a strong contamination control and data integrity culture within the filling operation.
Team Leadership- Recruit, hire, and build the filling operations organization to support filling operations and future manufacturing needs.
- Develop and implement onboarding, qualification, and ongoing training programs for operators and supervisors, including aseptic behavior, gowning, equipment operation, SOP execution, and GMP documentation practices.
- Manage, coach, and develop direct reports and establish clear roles, responsibilities, performance expectations, and accountability.
- Plan staffing levels and shift structures to ensure adequately trained resources are available to support production schedules and business priorities.
- Foster a strong culture of safety, quality, teamwork, operational discipline, and continuous improvement within the filling organization.
- Develop succession and cross-training plans to build operational flexibility and strengthen long-term team capability.
Cross-Functional Collaboration and Technical Support- Work closely with Engineering, Technical Services, and Validation during equipment commissioning, qualification, process validation, media fills, and manufacturing start-up activities.
- Support technical transfer and new product introduction by providing operational input for manufacturing procedures, batch records, equipment operation, and production readiness.
- Participate in development and review of manufacturing-related SOPs, batch records, process instructions, and training materials to ensure they are practical and suitable for routine operations.
- Serve as the primary Operations representative for sterile filling and provide operational input into process improvements.
- Collaborate with Quality, Supply Chain, Warehouse, and other support functions to ensure materials, personnel, documentation, and operational resources are available to support planned manufacturing activities.
- Identify operational risks and improvement opportunities and lead or support initiatives to improve equipment uptime, line efficiency, right-first-time performance, and overall manufacturing capability.
Qualifications- Excellent written and verbal communication skills, with strong attention to detail and clarity.
- Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline preferred.
- Minimum of 10 years of experience in pharmaceutical or biotechnology manufacturing, with significant experience in sterile injectable or aseptic filling operations.
- Demonstrated experience operating and managing aseptic filling lines; experience with vial, syringe, and/or cartridge filling is strongly preferred.
- Prior experience leading, hiring, training, and managing manufacturing teams in a GMP environment.
- Strong knowledge of sterile manufacturing principles, aseptic practices, contamination control, and current Good Manufacturing Practices (cGMP).
- Experience supporting facility start-up, equipment commissioning and qualification, process validation, media fills, technical transfer, or new product introduction is highly preferred.
- Experience preparing, reviewing, or implementing SOPs, batch records, work instructions, and other GMP manufacturing documentation.
- Strong understanding of deviation management, CAPA, change control, and investigation processes.
- Demonstrated leadership, problem-solving, organizational, and cross-functional collaboration skills.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
