NPI Program Manager — End-to-End Launch Leader

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia (Philadelphia County); Vor Ort; USD 110.000 - 140.000; Vollzeit

Zusammenfassung

PCI Pharma Services is seeking an experienced Project Manager to lead end-to-end NPI programs from award through commercialization. You will coordinate schedule, budget, and cross-functional teams, ensuring alignment with cGMP and FDA requirements, and you will communicate progress to stakeholders.

This role includes stage-gate management, technology transfer support, and ongoing process improvements. The ideal candidate has 4+ years in pharma project management, strong communication skills, and

Qualifikationen

• Bachelor’s degree in a technical, engineering, or science discipline.
• 4+ years of pharmaceutical project management experience.
• Knowledge of cGMP and FDA regulatory requirements.
• Experience managing integrated timelines, risks, escalation, and resolution.
• Proficiency with Smartsheet or equivalent project management platforms and Microsoft 365.

Aufgaben

• Own end-to-end project-level execution of NPI programs from award through commercialization.
• Maintain and manage project plans, action trackers, and RAID logs in Smartsheet; track milestones and risks.
• Lead cross-functional coordination across Engineering, QA, Operations, Procurement, Supply Chain, and Validation.
• Serve as the primary day-to-day operational contact for assigned clients; lead client steering committee meetings.
• Drive NPI stage-gate management and tech transfer activities; coordinate validation and launch readiness.
• Monitor scope, cost, and schedule; support CER submissions and BD-to-NPI handover; manage documentation.

Kenntnisse

Project management

Cross-functional coordination

Communication

Risk management

Problem solving

Detail oriented

Influence without authority

Customer focus

Ausbildung

Bachelor’s degree in technical, engineering, or science

Master’s degree (preferred)

Tools

Smartsheet

Microsoft 365

Jobbeschreibung

PCI Pharma Services is seeking an experienced Project Manager to lead end-to-end NPI programs from award through commercialization. You will coordinate schedule, budget, and cross-functional teams, ensuring alignment with cGMP and FDA requirements, and you will communicate progress to stakeholders.

This role includes stage-gate management, technology transfer support, and ongoing process improvements. The ideal candidate has 4+ years in pharma project management, strong communication skills, and