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.
Project Execution and Delivery
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.
Ensure all project activities follow the NPI Playbook and standard ways of working established by the NPI function.
Ensure all activities are performed in accordance with cGMP, FDA 21 CFR 211, applicable regulatory standards, and PCI SOPs and EHS requirements.
Cross-Functional Coordination
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.
Align Engineering, QA, Operations, and Supply Chain on technical requirements, material readiness, and validation plans. Ensure procurement timelines and material availability align with project milestones.
Customer and Stakeholder Communication
Serve as the primary day-to-day operational contact for assigned clients during active project execution, escalating strategic or relationship-level issues to the Program Manager.
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.
Provide internal and external project status reporting including schedule adherence, risk and issue summaries, and budget status as required.
Operational Readiness and Stage-Gate Management
Drive projects through formal NPI stage gates (Kickoff Development Tech Transfer Validation Commercialization), ensuring all gate deliverables are completed before phase transitions.
Work in close partnership with the Project Engineering team throughout the NPI lifecycle, ensuring alignment on equipment readiness, technical requirements, process development activities, and validation execution. Serve as a resource to the PE team for scheduling coordination, client communication, and cross-functional issue resolution.
Coordinate activities required for technology transfer, engineering runs, operational qualification (OQ), process line trials (PLT), process qualification (PQ/PPQ), and launch readiness, including in-person walkthroughs and alignment sessions on the manufacturing floor.
Ensure floor readiness and Business Unit resource availability prior to key manufacturing phases. Confirm batch records, Master Packaging Instructions (MPIs), specifications, and quality approvals are in place before validation runs.
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.
Ensure program timelines account for regulatory submissions, approvals, and inspection readiness milestones.
Financial and Scope Oversight
Monitor project scope against awarded work and identify potential scope changes, escalating to the Program Manager with supporting documentation for financial review.
Track key program cost drivers that could affect timeline, budget, or capacity planning and report variances to the Program Manager.
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.
Coordinate product destruction activities following completion of validation runs, ensuring proper documentation, client approvals, and compliance with PCI procedures and regulatory requirements.
Continuous Improvement
Capture lessons learned throughout the project lifecycle and contribute to improving the NPI Playbook, templates, and processes.
Provide feedback to the Program Manager on process gaps, operational challenges, and improvement opportunities identified during project execution.
Coordinate with internal change control processes to manage changes that affect project scope or timelines, ensuring proper documentation and approvals.
Scope and Authority
Influence-based leadership of cross-functional project teams with accountability for project-level deliverables and timelines.
Responsible for adhering to SOPs, Health & Safety, cGMP, and regulatory guidelines.
Authority to escalate project-level risks, scope changes, and issues to the Program Manager for resolution or further escalation.
This role requires occasional travel for vendor, supplier, or client engagements.
Qualifications:
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:
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.
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