PCI Pharma Services

PCI Pharma Services

Project Manager – NPI

Philadelphia, PA, USA

Sponsorship not specifiedDetected 35 days ago
ComplianceProject ManagementStakeholder ManagementBusiness DevelopmentSupply ChainProcurementGMPFDA RegulatoryLeadershipCommunicationProblem Solving

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.
  • Ensure procurement timelines and material availability align with project milestones.

Responsibilities

  • Own end-to-end project-level execution of assigned NPI programs from award through commercialization, managing the integrated project timeline including milestones, dependencies, and deliverables.
  • Maintain and manage project plans, action trackers, and RAID logs in Smartsheet. Track progress against milestones and escalate schedule, cost, or scope risks to the Program Manager early.
  • Prepare and deliver weekly project status updates for internal governance and leadership reporting, ensuring documentation, templates, and systems (Smartsheet, JDE) remain accurate and current.
  • Drive cross-functional coordination across Engineering, Quality Assurance, Quality Engineering, Operations, Procurement, Supply Chain, and Validation to ensure project deliverables stay on track.
  • Lead internal weekly project team meetings and ensure clear accountability for action items across all functional areas.
  • Lead or co-lead client steering committee meetings for assigned programs, preparing agendas, status materials, and action item tracking in coordination with the Program Manager.
  • Drive projects through formal NPI stage gates (Kickoff → Development → Tech Transfer → Validation → Commercialization), ensuring all gate deliverables are completed before phase transitions.
  • Track material readiness including components, tooling, and materials to ensure arrival in time for engineering and validation runs. Coordinate with Procurement and Supply Chain to resolve shortages or lead time issues.
  • Support timely submission of Capital Expenditure Requests (CERs) related to NPI programs and assist with on-boarding cost tracking as directed by the Program Manager.
  • Maintain a working relationship with Business Development to support the BD-to-NPI handover process, ensuring project-level inputs (technical requirements, commercial terms, timeline expectations) are captured accurately and incorporated into project plans.

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • Bachelor's degree in a technical, engineering, or science discipline.
  • 4+ years of experience in pharmaceutical project management, preferably within a CDMO or contract manufacturing environment.
  • Sound working knowledge of cGMP and FDA regulatory requirements.
  • Experience managing technical projects including integrated timeline management, risk identification, escalation, and resolution.
  • Proficiency with Smartsheet or equivalent project management platforms, and Microsoft 365 suite.
  • Strong communication skills with the ability to interact effectively with internal cross-functional teams and external clients.
  • 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 manage multiple concurrent projects with competing priorities and deadlines.
  • Strong problem-solving skills with an analytical, detail-oriented approach.
  • Ability to influence and drive accountability across cross-functional teams without direct authority.
  • Dependability, reliability, integrity, and attention to detail.
  • Customer-centric mindset with a commitment to quality, ethics, and professionalism.
  • Preferred:

Nice to have

  • Master's degree in a technical, engineering, or science discipline.
  • PMP, PRINCE2, or equivalent project management certification.
  • Experience with tech transfer, process validation (PLT/PQ/PPQ), or commercial manufacturing readiness activities.
  • Understanding of drug product manufacturing processes, equipment, and packaging operations.
  • Experience working directly with pharmaceutical clients as the primary operational point of contact.
  • Familiarity with stage-gate or phase-gated project management methodologies in a GMP manufacturing environment.

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.