PCI Pharma Services

PCI Pharma Services

Program Manager - NPI

Philadelphia, PA, USA

Sponsorship not specifiedDetected 26 days ago
ComplianceProject ManagementBusiness DevelopmentProcess ImprovementPerformance ManagementCadenceGMPFDA RegulatoryLeadershipCommunicationMentoring

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • The essential duties and responsibilities include the following but other duties may be assigned.
  • This role requires occasional travel for vendor, supplier, or client engagements, including potential travel to PCI Global sites.

Responsibilities

  • 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.
  • Own the reporting cadence to site leadership and identify trends requiring corrective action.
  • 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.
  • 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.
  • 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.
  • 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.
  • Identify opportunities for process improvement throughout the NPI lifecycle and collaborate with PCI Global sites to harmonize ways of working on large-scale programs.

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • Master's degree in a technical, engineering, or science discipline.
  • Experience with tech transfer, process validation (PPQ), and commercial manufacturing readiness.
  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Required:
  • Ability to lead and develop high-performing teams in a matrixed, cross-functional environment.
  • Ability to build trusted relationships with both internal stakeholders and external clients.

Nice to have

  • Bachelor's degree in a technical, engineering, or science discipline.
  • 7+ years of experience in pharmaceutical project or program management, including oversight of multi-million dollar NPI, tech transfer, or capital programs.
  • Proven experience managing concurrent programs across multiple clients in a CDMO or contract manufacturing environment.
  • Sound working knowledge of cGMP, FDA 21 CFR 211, and regulatory inspection readiness.
  • Experience serving as the primary client point of contact, including participation in JSC meetings and steering committees.
  • Direct people management experience, including performance management, coaching, and team development.
  • Proficiency with project management and reporting tooling, including demonstrated ability to build dashboards, trackers, and reporting infrastructure in Smartsheet or equivalent platforms, plus Microsoft 365 suite.
  • Effective communication across all levels, including executive stakeholders and external clients.

Benefits

  • Manage program-level budgets on behalf of site leadership, including Capital Expenditure (CapEx) tracking, benefits realization reporting, and variance analysis.
  • Responsible for adherence to SOPs, Health & Safety, cGMP, and regulatory guidelines for themselves, their team, and any contractors under their direction.

Company info

  • Together, delivering life-changing therapies.
  • We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
  • We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Equal opportunity

  • PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Visa & Work Authorization

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.