Senior Manager Manufacturing – Production Process Owners

Senior Manager, Manufacturing Programs – Production Process Owners

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• Lead, coach, mentor, and develop the manufacturing process owners within the manufacturing organization.
• Foster a culture of collaboration, continuous improvement, accountability, and high performance across the team.
• Provide guidance, performance feedback, and support for career development plans for direct reports.
• Set clear priorities, define role clarity, and establish coverage plans so the PPO team can flex across site needs, emerging issues, and evolving operational demands.

• Ensure strong collaboration and coordination between Manufacturing and key partners such as Quality, Facilities and Engineering, Automation, Supply Chain, Maintenance, and other site functions.
• Provide governance and execution support to ensure smooth, compliant, and reliable manufacturing operations.
• Manage and improve manufacturing processes to increase productivity, reduce waste, and maintain product quality and compliance.
• Strengthen process discipline, documentation quality, and operational readiness across site processes.
• Serve as an escalation point for complex execution topics, ensuring issues are evaluated, decisions are made with the right stakeholders, and actions are closed with discipline.

• Ensure manufacturing activities are performed in compliance with cGMP and all applicable regulatory requirements and internal quality standards.
• Support inspection and audit readiness by ensuring appropriate documentation, escalation pathways, and governance transparency.
• Support site teams that own compliance‑critical programs, including aseptic compliance and validation‑related execution, by helping prioritize resources and drive timely resolution of issues.
• Ensure disciplined execution and timely closure of quality actions, CAPAs, and effectiveness verification activities in partnership with Quality and subject matter experts.
• Support and reinforce a strong safety culture and a safe working environment for all employees.

• Provide oversight and drive process improvement initiatives aimed at increasing efficiency, improving reliability, reducing costs, and enhancing the drug product manufacturing process.
• Use lean manufacturing and other continuous improvement tools to identify opportunities and optimize operations.
• Analyze operational and quality data to identify trends, solve complex problems, and implement corrective actions.

• Partner with site stakeholders to ensure readiness for new processes, new products, and major operational changes.
• Support risk identification, issue resolution, and execution readiness across impacted functions and unit operations.
• Facilitate, or ensure strong facilitation of, key site governance forums used to align priorities, remove barriers, and drive execution.
• Support the site project governance operating model, including plant project prioritization, by driving disciplined intake, prioritization, execution tracking, and escalation when needed.
• Act as a point of contact for process owners during troubleshooting and resolution of manufacturing‑related issues.

• Stay current on technological advancements and assess opportunities for adoption in the plant.
• Support introduction and scale‑up of new technologies, equipment, and systems that enhance production capabilities and improve operational performance.
• Partner cross‑functionally to ensure technology‑related changes are effectively planned, implemented, and sustained.

• Doctorate degree and 2 years of Manufacturing and Operations experience OR
• Master’s degree and 6 years of Manufacturing and Operations experience OR
• Bachelor’s degree and 8 years of Manufacturing and Operations experience OR
• Associate’s degree and 10 years of Manufacturing and Operations experience OR
• High school diploma / GED and 12 years of Manufacturing and Operations experience

In addition to meeting at least one of the above requirements,…