Project Manager – NPI

Responsibilities

• Own end-to-end execution of New Product Introduction (NPI) programs from award through commercialization.
• Manage integrated project timelines, milestones, dependencies, and deliverables using Smartsheet.
• Drive cross-functional coordination across Engineering, Quality, Operations, Procurement, and Supply Chain.
• Serve as the primary day-to-day operational contact for assigned clients.
• Lead projects through formal NPI stage gates, including technology transfer, validation, and launch readiness.
• Monitor project scope and track cost drivers to ensure alignment with awarded work and budgets.
• Ensure all activities comply with cGMP, FDA 21 CFR 211, and internal SOPs.

Requirements

• Bachelor's degree in a technical, engineering, or science discipline.
• 4+ years of pharmaceutical project management experience, preferably in a CDMO or contract manufacturing environment.
• Strong working knowledge of cGMP and FDA regulatory requirements.
• Proficiency in Smartsheet and the Microsoft 365 suite.
• Proven experience managing technical projects, including risk identification and resolution.
• Ability to influence cross-functional teams and manage multiple concurrent projects.

Preferred Qualifications

• Master's degree in a technical, engineering, or science discipline.
• PMP, PRINCE2, or equivalent project management certification.
• Experience with tech transfer, process validation (PLT/PQ/PPQ), or commercial manufacturing readiness.
• Understanding of drug product manufacturing processes and packaging operations.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between biopharma companies and their patients. We focus on delivering life-changing therapies through operational excellence and a commitment to quality and innovation.