Manager, Packaging & Inspection- 2nd Shift

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make
The Manager, Packaging & Inspection (PM Shift), is responsible for providing cross-functional operational leadership for evening shift Packaging and Inspection operations within a contract development and manufacturing organization (CDMO) environment at Kindeva's Maryland Heights location. This role provides direct leadership and oversight for PM shift execution across sterile injectable and combination product packaging and visual inspection operations supporting vials, cartridges, prefilled syringes, and auto-injector products for commercial and government programs.

Role Responsibilities
• Provide direct operational leadership for PM shift Packaging and Inspection operations, ensuring safe, compliant, and efficient execution of manufacturing activities.
• Ensure PM shift operations are executed in compliance with cGMP requirements, data integrity standards, internal procedures, and customer and regulatory requirements.
• Lead and develop supervisors and unionized personnel by establishing clear expectations and driving accountability for safety, quality, compliance, productivity, and schedule attainment.
• Coordinate daily execution across Packaging, MVI, SAVI, and AVI operations to support production schedules and maintain uninterrupted product flow.
• Serve as the primary escalation point for PM shift operational issues, partnering cross-functionally to resolve manufacturing, staffing, equipment, material, and quality-related challenges.
• Partner closely with AM Packaging and Inspection leadership to ensure alignment of operational priorities, staffing plans, escalation processes, and performance expectations across shifts.
• Support troubleshooting and operational decision-making related to packaging and inspection processes while escalating technical or program-level issues to appropriate functional SMEs.
• Drive shift-level operational excellence and continuous improvement initiatives focused on safety, efficiency, compliance, labor utilization, and throughput performance.
• Ensure manufacturing areas maintain inspection readiness and comply with 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 company and regulatory requirements.
• Support audits, inspections, investigations, deviations, CAPAs, and change control activities as required.
• 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.

Basic Qualifications
• Bachelor's degree in Engineering, Pharmaceutical Sciences, Life Sciences, Operations Management, or related technical discipline.
• 5+ years of experience in pharmaceutical, biologics, medical device, or combination product manufacturing environments.
• Demonstrated operational experience supporting regulated manufacturing operations within sterile pharmaceutical or combination product manufacturing environments preferred.
• Broad understanding of pharmaceutical packaging operations and/or visual inspection processes, including automated manufacturing systems and regulated production environments.
• Demonstrated knowledge of current Good Manufacturing Practices (cGMP), data integrity requirements, and domestic and international regulatory expectations associated with pharmaceutical manufacturing operations.
• Experience leading teams within a union manufacturing environment preferred.
• Demonstrated ability to lead cross-functional manufacturing operations and manage competing priorities in a fast-paced CDMO environment.
• Experience supporting investigations, deviations, CAPAs, audits, and operational escalation management within regulated manufacturing environments preferred.
• Strong leadership, coaching, communication, organizational, and problem-solving skills with the ability to drive accountability and team engagement across multiple operational areas.
• Demonstrated ability to analyze operational data and manufacturing performance metrics to support decision-making, troubleshooting, and continuous improvement initiatives.

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Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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