Project Manager, Operational Readiness and Excellence

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

The Project Manager, Operational Readiness & Excellence plays a critical enabling role in ensuring that the newly constructed GMP biotech drug substance manufacturing facility is fully prepared for efficient, compliant, and high-quality operations from day one. This role bridges the transition from project completion to sustained performance by integrating Operational Readiness (OR) planning with Operational Excellence (OE) principles.

You will be responsible for coordinating, executing, and tracking cross-functional initiatives that align readiness and continuous improvement with construction, commissioning, and departmental strategies. This includes managing stakeholder expectations, facilitating risk mitigation, and enabling readiness programs that deliver right-first-time outcomes, cost-effectiveness, and long-term operational optimization.

While the primary focus is on-site execution, the role also requires engagement with regional and global stakeholders to ensure alignment with enterprise-level initiatives.

This is a transitional role that evolves in scope as the site moves from startup to steady-state operations:
•    Phase 1 – Operational Readiness (through 2027):
Implement integrated readiness plans across all functions. Manage detailed schedules, coordinate critical path activities, and ensure systems, processes, and personnel are fully prepared to initiate GMP manufacturing operations. Facilitate decision-making, escalate risks, and align stakeholders to maintain delivery momentum.
•    Phase 2 – Operational Excellence (post-2027):
Lead site-wide and global improvement initiatives using Lean Six Sigma and other CI methodologies. Deliver measurable results by optimizing processes, standardizing best practices, and embedding a culture of performance, accountability, and continuous improvement.

This is a hands-on, execution-focused role requiring strong project management, change leadership, and communication skills to drive outcomes and influence decisions across diverse stakeholders.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

•    Phase I reporting to Manager, SCM Business Operations Performance; dotted line to Senior Manager, Operational Excellence
•    Phase II reporting to Senior Manager, Operational Excellence

Technical Skills, Knowledge, and Experience :

Phase 1: Operational Readiness – Greenfield Startup
Integrated Schedule Management
•    Manage Level 1–4 integrated schedules across all readiness workstreams.
•    Partner with cross-functional leads and teams to define activities, dependencies, durations, and milestones.
•    Monitor schedule performance, identify risks and delays, and drive resolution of interdependencies.
•    Conduct scenario planning and “what-if” analyses to support decision-making and schedule acceleration.
•    Prepare and deliver executive-level dashboards and reports on schedule health and progress.

Workstream Execution
•    Lead and/or facilitate cross-functional workshops to align teams, resolve issues, and drive accountability.
•    Coordinate readiness activities across various functional stakeholders including Quality, Engineering, EHS, Manufacturing, Supply Chain, Procurement, ICT Digital Systems, Facilities and Maintenance, HR, and Finance.
•    Facilitate stakeholder alignment and decision-making to maintain momentum and resolve blockers.

Governance &