PHL_Program Manager-NPI

pciservices; Philadelphia (Philadelphia County); On-site; USD 120,000 - 180,000; Full time

Job summary

PCI Services in Philadelphia is seeking an experienced NPI Program Manager to own end-to-end delivery of new product introductions. You will coordinate across Manufacturing, Quality, Engineering, and Supply Chain to ensure on-time launches and commercial readiness.

The role requires driving risk mitigation, managing program budgets, and ensuring adherence to cGMP and FDA guidelines. Strong leadership and strategic thinking are essential for success in a fast-paced biopharma environment.

Qualifications

• Experience leading end-to-end NPI programs is required.
• Strong cross-functional leadership across Manufacturing, Quality, Engineering and Supply Chain.
• Budget management experience for site level programs is preferred.
• Knowledge of cGMP requirements and regulatory guidelines (FDA) is essential.

Responsibilities

• Own end-to-end delivery of NPI programs including tech transfer, process development, engineering runs, training runs, PPQ, and commercial handoff.
• Compile and maintain integrated program timelines with critical path, milestones and interdependencies.
• Proactively identify risks and drive mitigation plans to completion.
• Manage program budgets, CapEx tracking and variance analysis for site leadership.
• Ensure NPI activities comply with SOPs, cGMP and regulatory standards.
• Define and report NPI performance metrics to site leadership.

Skills

NPI program management

Cross-functional leadership

Budget management

cGMP regulatory knowledge

Regulatory awareness (FDA/ICh)

Smartsheet proficiency

Tools

Smartsheet

Job description

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.

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.

Program Execution and Delivery

Own end-to-end delivery of NPI programs spanning tech transfer, process development, engineering runs, training runs, process validation (PPQ), and commercial handoff, coordinating across Manufacturing, Quality, Engineering, and Supply Chain.

Compile and maintain integrated program timelines identifying critical path activities, key milestones, and interdependencies. Proactively identify risks and drive mitigation plans through completion.

Manage program-level budgets on behalf of site leadership, including Capital Expenditure (CapEx) tracking, benefits realization reporting, and variance analysis.

Ensure all NPI activities comply with PCI procedures, cGMP requirements, and applicable regulatory standards (FDA 21 CFR 211, ICH guidelines).

Define and report on NPI performance metrics including launch on-time performance, validation success rate, budget variance, and cycle time from award to commercialization. Own the reporting cadence to site leadership and identify trends requiring corrective action.

Client Management

Serve as the primary PCI point of contact for assigned NPI clients throughout the program lifecycle, representing PCI in Joint Steering Committee (JSC) meetings, on-site reviews, and steering committee sessions.

Drive Right First Time (RFT) and On Time In Full (OTIF) delivery across all client programs, proactively managing expectations and communicating status, risks, and escalations through structured governance cadences.

Team Leadership

Directly manage and develop a team of NPI Project Managers, setting clear performance expectations, providing coaching and mentorship, and building program management capability within the NPI function.

Promote engagement and accountability at all levels of the program team, ensuring individuals understand their contributions to program success and client outcomes.

NPI Strategy and Function Development

Partner with the Director of NPI to define and evolve the NPI operating model, including program tiering frameworks, phase-gated process design, resource allocation models, and standardized governance structures (JSC cadences, kickoff protocols, handoff criteria).

Lead the implementation of NPI strategic initiatives across the Philadelphia site, translating directional strategy into executable plans, standard work, and measurable outcomes.

Contribute to the development of NPI client onboarding standards, training and readiness frameworks, and internal playbook documentation that codify how the function operates at scale.

Design and own the Business Development-to-NPI handover process, defining documentation standards (TKO from Engineering, product detail sheets, launch questionnaires), technical inputs, billing setup, and internal launch preparation steps to ensure programs are fully scoped and resourced before customer kickoff.

Develop and maintain an NPI training curriculum and on-the-job training (OJT) framework for Project Managers and Associate Project Managers, including standard work definitions that establish consistent execution expectations across the team.

Cross-Functional Coordination and Continuous Improvement

Work cross-functionally to evaluate and coordinate resource allocation across programs, ensuring appropriate capacity within each functional team and that deliverables are tracked to completion.

Identify opportunities for process improvement throughout the NPI lifecycle and collaborate with PCI Global sites to harmonize ways of working on large-scale programs.

Manage change at varying levels, ensuring site procedures are followed and change controls are raised with the appropriate approvers engaged from the outset.

Own portfolio-level health monitoring across all active NPI programs, including schedule risk assessment, resource prioritization when constrained, validation readiness tracking, and revenue impact analysis for site leadership reporting.

Build and maintain NPI reporting infrastructure in Smartsheet, including operational dashboards for program managers and executive-level dashboards for SLT, with standardized RAID logs and lessons learned integrated into every program provision.

Scope and Authority

Direct management of NPI Project Managers with responsibility for performance management, development, and workload allocation.

Responsible for adherence to SOPs, Health & Safety, cGMP, and regulatory guidelines for themselves, their team, and any cont