Specialist Manufacturing, New Product Introduction

About the Role

You will be responsible for the introduction of new products into the manufacturing plant as the New Product Introduction (NPI) Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team at ATO B20. This role serves as a vital interface between five key functions: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. You will drive decision-making, impose timelines, and lead cross-functional projects to deliver NPIs on time through effective indirect people management and communication.

Responsibilities

• Develop, maintain, and implement NPI project plans, ensuring accountability for scope, schedule, and risk management.
• Lead matrixed teams through influence to meet NPI project milestones.
• Resolve issues promptly and escalate cross-functional concerns to management as needed.
• Own Change Controls in Trackwise, ensuring comprehensive and GMP-compliant records with a Right-First-Time approach.
• Proactively lead cross-functional team meetings to ensure NPI projects and business cases execute on schedule.
• Communicate succinctly—verbally, in writing, and through presentations—to peers and senior leadership.
• Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and agency submissions.
• Hold supporting functions accountable for NPI project tasks, documenting Lessons Learned and presenting to management when appropriate.
• Review protocols for manufacturing activities and partner with Quality Assurance to maintain GMP standards per SOPs, batch records, and licenses.
• Identify and implement process improvement opportunities within the organization.
• Conduct Gemba walks in the manufacturing plant to identify NPI-related process improvements and lifecycle management strategies.
• Report on team and plant metrics to ensure visibility of operations and deliverables.
• Represent the team at plant-wide and network-wide forums as needed.

Requirements

• Knowledge of Drug Product (DP) technical processes, manufacturing operations, scientific methods, and basic regulatory compliance expectations.
• Quantitative and analytical troubleshooting skills.
• Experience with regulated environments (e.g., cGMP).

Preferred Qualifications

• Project Management experience.
• Direct and/or indirect people management or leadership experience.
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations.
• Experience with quality systems, including change control, deviations, corrective and preventative actions, and/or validation practices.
• Strong organization and technical writing skills; ability to articulate complex problems concisely.
• Independent, self-motivated, and able to multi-task in a fast-paced environment.
• Demonstrated flexibility and ability to manage change.
• Team-player mindset.

Pay

Target pay range: $25–$35 per hour, depending on experience.