NPI Project Lead - End-to-End Pharma Development

PCI Pharma Services; Philadelphia (Philadelphia County); Presencial; USD 90.000 - 140.000; Jornada completa

Descripción de la vacante

PCI Pharma Services in Philadelphia seeks an experienced Pharmaceutical Project Manager to drive end-to-end NPI programs from award through commercialization. You will manage integrated timelines, RAID logs, and weekly status updates, while aligning Engineering, QA, Operations, and Supply Chain on requirements and validation plans.

You will lead cross-functional teams, communicate with clients, and ensure regulatory readiness, stage-gate milestones, and budget adherence throughout the lifecycle

Formación

• Bachelor's degree in a technical, engineering, or science field.
• 4+ years of pharmaceutical project management experience.
• Knowledge of cGMP and FDA regulatory requirements.
• Managing technical projects with integrated timeline, risk escalation, and resolution.
• Proficiency with Smartsheet or comparable PM platforms; MS 365 suite.
• Strong communication with cross-functional teams and clients.
• Ability to juggle multiple concurrent projects and deadlines.
• Strong problem-solving, analytical, and detail-oriented approach.
• Ability to influence cross-functional teams without direct authority.

Responsabilidades

• Own end-to-end project execution of NPI programs from award to commercialization.
• Maintain project plans, action trackers, and RAID logs; track milestones.
• Prepare weekly status updates for governance and leadership reporting.
• Ensure activities follow the NPI Playbook and SOPs, and regulatory standards.
• Drive cross-functional coordination across Engineering, QA, Operations, and Supply Chain.
• Lead or co-lead client steering committee meetings; manage action items.
• Provide internal/external status reporting including schedule, risks, and budget.
• Manage technology transfer, OQ/PLT/PQ/PPQ, and launch readiness activities.
• Coordinate with Procurement and Supply Chain to resolve shortages and lead times.
• Monitor scope and costs; submit CERs and assist with cost tracking.
• Capture lessons learned and contribute to process improvements.
• Escalate risks, scope changes, and issues to Program Manager for resolution.

Conocimientos

Project management

Cross-functional leadership

Risk management

Communication

Schedule management

Team collaboration

Problem solving

Influence without authority

Multitasking

Educación

Bachelor's degree in technical/engineering/science

Master's degree in technical/engineering/science (preferred)

Herramientas

Smartsheet

Microsoft 365

Descripción del empleo

PCI Pharma Services in Philadelphia seeks an experienced Pharmaceutical Project Manager to drive end-to-end NPI programs from award through commercialization. You will manage integrated timelines, RAID logs, and weekly status updates, while aligning Engineering, QA, Operations, and Supply Chain on requirements and validation plans.

You will lead cross-functional teams, communicate with clients, and ensure regulatory readiness, stage-gate milestones, and budget adherence throughout the lifecycle