Program Manager - NPI

Responsibilities

• Own end-to-end delivery of New Product Introduction (NPI) programs, including tech transfer, process development, engineering runs, and commercial handoff.
• Manage integrated program timelines, identifying critical path activities, milestones, and interdependencies while driving risk mitigation plans.
• Oversee program-level budgets, including Capital Expenditure (CapEx) tracking and variance analysis.
• Serve as the primary point of contact for NPI clients, representing the company in Joint Steering Committee (JSC) meetings and governance sessions.
• Directly manage and develop a team of NPI Project Managers through coaching, mentorship, and performance management.
• Partner with leadership to evolve the NPI operating model, including phase-gated process design and resource allocation models.
• Ensure all NPI activities comply with cGMP requirements and regulatory standards such as FDA 21 CFR 211.

Requirements

• Bachelor's degree in a technical, engineering, or science discipline.
• 7+ years of pharmaceutical project or program management experience, specifically overseeing NPI, tech transfer, or capital programs.
• Proven experience managing concurrent programs within a CDMO or contract manufacturing environment.
• Direct people management experience, including coaching and team development.
• Strong knowledge of cGMP and FDA 21 CFR 211 regulations.
• Proficiency in Smartsheet and the Microsoft 365 suite for building dashboards and reporting infrastructure.
• Excellent communication skills for engaging with executive stakeholders and external clients.

Preferred Qualifications

• Master's degree in a technical, engineering, or science discipline.
• PMP, PRINCE2, or equivalent project management certification.
• Experience with process validation (PPQ) and commercial manufacturing readiness.
• Experience building operational strategies or governance frameworks within a GMP environment.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We invest in people who drive progress and create a better tomorrow through quality, operational excellence, and an industry-leading customer experience.