Manager, Packaging Operations

Responsibilities

• Lead and own all packaging operations for sterile injectable and combination products, serving as Subject Matter Expert during audits and regulatory inspections.
• Ensure all packaging operations are executed in compliance with cGMP requirements, data integrity standards, internal procedures, and customer and regulatory requirements.
• Partner with Quality and Regulatory teams to support audits, inspections, investigations, deviations, CAPAs, and change control activities.
• Build and lead a high-performance team by coaching and developing supervisors and unionized personnel, establishing clear expectations, and driving accountability for safety, quality, compliance, productivity, and operational objectives.
• Ensure packaging operations are appropriately staffed and scheduled to meet production demands while partnering with Inspection and upstream operations to maintain coordinated product flow and minimize disruptions.
• Drive continuous improvement using operational excellence and structured problem-solving to enhance reliability, efficiency, and throughput.
• Partner cross-functionally with Engineering, Validation, Maintenance, and Technical Services to support implementation, qualification, optimization, and performance of packaging systems.
• Support new customer onboarding, technology transfers, and implementation of new packaging capabilities required to support future business growth and evolving customer requirements.
• Ensure packaging areas maintain inspection readiness and meet safety, housekeeping, and environmental requirements.
• Ensure all employees are appropriately trained and qualified for assigned responsibilities and that training documentation is maintained in accordance with organizational and regulatory requirements.
• Maintain effective working relationships with union representatives and ensure compliance with collective bargaining agreements and company policies.
• Communicate effectively with internal stakeholders, site leadership, customers, and regulatory agencies as required.

Qualifications

• Bachelor’s degree in a relevant technical field or scientific field
• 7+ years of manufacturing experience in pharmaceutical, biotech, medical device, or combination product manufacturing environments
• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), data integrity requirements, and applicable domestic and international regulatory requirements governing pharmaceutical and combination product manufacturing
• Proven leadership experience in manufacturing environments, including development of supervisors and frontline personnel; union manufacturing experience preferred
• Experience supporting automated packaging systems, labeling, cartoning, serialization, packaging line integration, equipment implementation, qualification, startup, and technology transfer activities preferred
• Proven ability to drive operational excellence, continuous improvement, and cross-functional collaboration in a fast-paced Contract Development and Manufacturing Organization (CDMO) environment
• Strong leadership, communication, organizational, and problem-solving skills with the ability to manage multiple priorities, drive accountability, and effectively interact with customers, regulators, and all levels of the organization
• Demonstrated ability to analyze production data and operational metrics to drive performance, troubleshoot issues, and support continuous improvement initiatives