Senior Project Manager

The Senior Project Manager leads the technical and commercial execution of multiple client programs for sterile, unit-dose products manufactured by Blow-Fill-Seal (BFS) aseptic processing — from feasibility and technology transfer through registration batches, process validation, launch, and ongoing commercial supply. This customer- facing role is the primary point of contact for assigned clients and directs cross-functional teams across the site. It is the senior individual-contributor role within the Project Management Office and is positioned as a development role for progression into Project Management leadership: the incumbent is expected to mentor project managers, act as designee for the Director of Project Management, and take an increasing share of portfolio-level and PMO governance responsibility.

Key Responsibilities:

• Lead assigned client programs end to end for sterile BFS products — feasibility, quotation support, technology transfer, engineering and registration/exhibit batches, process validation (PPQ), stability, launch, and commercial supply.
• Serve as the primary customer contact and own the relationship at both working and executive level, including project review meetings, business reviews, and joint steering committees.
• Develop and maintain integrated project schedules, critical-path and resource analyses, risk registers, and milestone tracking tools. Report any variance as soon as it is recognized, together with a recovery plan.
• Direct cross-functional teams — Product Development, Analytical Services, Quality, Operations, Engineering, Supply Chain, Regulatory Affairs, and Finance — without direct reporting authority.
• Own project scope and change control: identify out-of-scope work, develop and negotiate change orders, and support quoting, revenue forecasting, and cash-flow phasing with Finance.
• Coordinate regulatory deliverables with Regulatory Affairs in support of ANDA, NDA/505(b)(2), and post-approval submissions, including customer data packages and response timelines.
• Represent Project Management in customer audits, technical visits, and regulatory inspections; coordinate cross-functional responses to customer technical queries and audit observations.
• Mentor and provide day-to-day direction to Project Managers, Associate Project Managers, and Project Coordinators, including review of their project plans and customer-facing deliverables.
• Serve as designee for the Director of Project Management as assigned, including portfolio reporting to site leadership and representation in leadership and governance meetings.
• Advance PMO capability — stage-gate standards, templates, project KPIs and dashboards, and lessons- learned reviews at program close.
• Establish and maintain internal and external meeting agendas and minutes as the controlled record of project decisions.