Project Manager – NPI

PCI Pharma Services•Philadelphia, PA

About The Position

The Project Manager – NPI owns project-level execution of assigned new product introduction (NPI) programs from award through commercialization. The role manages integrated timelines, milestones, dependencies, deliverables, project plans, action trackers, and risk, assumption, issue, and dependency (RAID) logs, while escalating schedule, cost, and scope risks to the Program Manager. The Project Manager coordinates cross-functional teams and serves as the day-to-day operational contact for assigned clients, supporting status reporting, steering committee meetings, and issue resolution. The role drives programs through NPI stage gates, including kickoff, development, technology transfer, validation, and commercialization. In partnership with Project Engineering and other functions, it coordinates engineering runs, operational qualification, process line trials, process qualification, validation, and launch readiness. It also tracks operational readiness, material availability, financial and scope considerations, regulatory milestones, and project documentation. Work must comply with cGMP, FDA 21 CFR 211, applicable regulatory standards, PCI SOPs, and EHS requirements. The position requires occasional travel for vendor, supplier, or client engagements.

Requirements

Bachelor’s degree in a technical, engineering, or science discipline.
At least 4 years of experience in pharmaceutical project management, preferably within a CDMO or contract manufacturing environment.
Sound working knowledge of cGMP and FDA regulatory requirements.
Experience managing technical projects, including integrated timeline management, risk identification, escalation, and resolution.
Proficiency with Smartsheet or equivalent project management platforms and the Microsoft 365 suite.
Strong communication skills and ability to interact effectively with internal cross-functional teams and external clients.
Ability to manage multiple concurrent projects with competing priorities and deadlines.
Strong problem-solving skills and an analytical, detail-oriented approach.
Ability to influence cross-functional teams and drive accountability without direct authority.
Dependability, reliability, integrity, and attention to detail.
Customer-centric mindset and commitment to quality, ethics, and professionalism.

Nice To Haves

Master’s degree in a technical, engineering, or science discipline.
PMP, PRINCE2, or equivalent project management certification.
Experience with technology transfer, process validation (PLT/PQ/PPQ), or commercial manufacturing readiness activities.
Understanding of drug product manufacturing processes, equipment, and packaging operations.
Experience working directly with pharmaceutical clients as the primary operational point of contact.
Familiarity with stage-gate or phase-gated project management methodologies in a GMP manufacturing environment.

Responsibilities

Own end-to-end project-level execution of assigned NPI programs from award through commercialization.
Manage integrated project timelines, milestones, dependencies, deliverables, project plans, action trackers, and RAID logs.
Track progress and escalate schedule, cost, scope, and project risks to the Program Manager.
Prepare and deliver weekly project status updates and maintain accurate project documentation and systems.
Ensure project activities follow the NPI Playbook, standard ways of working, cGMP, FDA 21 CFR 211, regulatory standards, PCI SOPs, and EHS requirements.
Coordinate cross-functional work across Engineering, Quality Assurance, Quality Engineering, Operations, Procurement, Supply Chain, and Validation.
Lead internal weekly project team meetings and ensure accountability for action items.
Align teams on technical requirements, material readiness, validation plans, procurement timelines, and project milestones.
Serve as the primary day-to-day operational contact for assigned clients, escalating strategic or relationship-level issues to the Program Manager.
Lead or co-lead client steering committee meetings and prepare agendas, status materials, and action tracking.
Provide internal and external project reporting on schedules, risks, issues, and budget status as required.
Drive projects through NPI stage gates and ensure gate deliverables are complete before phase transitions.
Partner with Project Engineering on equipment readiness, technical requirements, process development, validation execution, scheduling, client communication, and cross-functional issue resolution.
Coordinate technology transfer, engineering runs, OQ, PLT, PQ/PPQ, and launch-readiness activities, including manufacturing-floor walkthroughs and alignment sessions.
Ensure floor readiness and Business Unit resource availability before key manufacturing phases.
Confirm batch records, Master Packaging Instructions, specifications, and quality approvals are in place before validation runs.
Track material readiness and coordinate with Procurement and Supply Chain to address shortages and lead-time issues.
Ensure timelines account for regulatory submissions, approvals, and inspection-readiness milestones.
Monitor project scope against awarded work, identify potential scope changes, and escalate them with supporting documentation for financial review.
Track program cost drivers and report variances that may affect timelines, budgets, or capacity planning.
Support timely submission of Capital Expenditure Requests and assist with onboarding cost tracking as directed.
Work with Business Development on BD-to-NPI handover, ensuring technical requirements, commercial terms, and timeline expectations are captured in project plans.
Coordinate product destruction after validation runs, including documentation, client approvals, and regulatory and PCI procedure compliance.
Capture lessons learned and contribute to improvements to the NPI Playbook, templates, and processes.
Provide feedback on process gaps and operational challenges, and coordinate change control for changes affecting scope or timelines.
Adhere to SOPs, health and safety requirements, cGMP, and regulatory guidelines; escalate project-level risks, scope changes, and issues to the Program Manager.
Travel occasionally for vendor, supplier, or client engagements.