PHL_Project Manager – NPI

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

NPI Project Manager initiates, coordinates and manages designated customer projects to ensure that both PCI and client are aligned for project success, establishing timeline and orchestrating critical developmental steps and milestones to ensure successful commercialization within prescribed time frame and budget.  Working with dedicated NPI team, NPI PM is the new project architect, designing and leading in integral activities to foster project success, providing PCI a competitive advantage in short term and long-term customer management through an industry leading customer experience. 

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Project Execution and Delivery

• Own end-to-end project-level execution of assigned NPI programs from award through commercialization, managing the integrated project timeline including milestones, dependencies, and deliverables.
• Maintain and manage project plans, action trackers, and RAID logs in Smartsheet. Track progress against milestones and escalate schedule, cost, or scope risks to the Program Manager early.
• Prepare and deliver weekly project status updates for internal governance and leadership reporting, ensuring documentation, templates, and systems (Smartsheet, JDE) remain accurate and current.
• Ensure all project activities follow the NPI Playbook and standard ways of working established by the NPI function.
• Ensure all activities are performed in accordance with cGMP, FDA 21 CFR 211, applicable regulatory standards, and PCI SOPs and EHS requirements.

Cross-Functional Coordination

• Drive cross-functional coordination across Engineering, Quality Assurance, Quality Engineering, Operations, Procurement, Supply Chain, and Validation to ensure project deliverables stay on track.
• Lead internal weekly project team meetings and ensure clear accountability for action items across all functional areas.
• Align Engineering, QA, Operations, and Supply Chain on technical requirements, material readiness, and validation plans. Ensure procurement timelines and material availability align with project milestones.

Customer and Stakeholder Communication

• Serve as the primary day-to-day operational contact for assigned clients during active project execution, escalating strategic or relationship-level issues to the Program Manager.
• Lead or co-lead client steering committee meetings for assigned programs, preparing agendas, status materials, and action item tracking in coordination with the Program Manager.
• Provide internal and external project status reporting including schedule adherence, risk and issue summaries, and budget status as required.

Operational Readiness and Stage-Gate Management

• Drive projects through formal NPI stage gates (Kickoff → Development → Tech Transfer → Validation → Commercialization), ensuring all gate deliverables are completed before phase transitions.
• Work in close partnership with the Project Engineering team throughout the NPI lifecycle, ensuring alignment on equipment readiness, technical requirements, process development activities, and validation execution. Serve as a resource to the PE team for scheduling coordination, client communication, and cross-functional issue resolution.
• Coordinate activities required for technology transfer, engineering runs, operational qualification (OQ), process line trials (PLT), process qualification (PQ/PPQ), and launch readiness, including in-person walkthroughs and alignment sessions on the manufacturing floor.
• Ensure floor readiness and Business Unit resource availability prior to key manufacturing phases. Confirm batch records, Master Packaging Instructions (MPIs), specifications, and quality approvals are in place before validation runs.
• Track material readiness including components, tooling, and materials to ensure arrival in time for engineering and validation runs. Coordinate with Procurement and Supply Chai