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 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 organizations 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 14 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 & Risk Management
Maintain and manage the operational readiness risk register.
Proactively identify and mitigate risks associated with process integration resource limitations and scheduling conflicts in collaboration with functional owners.
Drive governance routines and provide visibility to senior leadership and project sponsors.

Phase 2: Operational Excellence Post-Launch
Process Improvement Execution
Evaluate operational processes to identify inefficiencies bottlenecks and waste.
Develop and implement short- and long-term strategies for process optimization.
Facilitate and lead root cause analyses Kaizen events and structured problem-solving workshops.
Drive execution of Continuous Improvement (CI) projects with clear goals timelines and measurable outcomes.

Lean & Six Sigma Application
Apply Lean Six Sigma 5S and Value Stream Mapping to improve throughput quality and cost.
Standardize processes and embed best practices across production lines support functions and applicable global operations.

Change Management & Capability Building
Utilize change management methods to ensure successful adoption of new processes technologies and behaviors.
Coach and mentor team members in CI tools Lean principles and zero-waste mindsets.
Build CI capability across the organization through structured training engagement programs and recognition of improvement efforts.

Performance Monitoring & Strategic Impact
Partner with cross-functional and cross-regional leaders to define monitor and report on key performance indicators (KPIs).
Analyze performance trends and lead proactive actions to sustain and scale improvements.

This role is an Individual contributor with responsibility to lead or work with cross-functional project teams.

Education
Bachelors degree in Engineering (Chemical Biomedical Process Industrial) Life Sciences (Biotechnology Biology Chemistry Pharmaceutical Sciences) Business Administration or Operations Management
Masters degree is a plus
Preferred certifications:
o Project Management Professional (PMP) or equivalent
o Lean Six Sigma Green Belt or Black Belt
o Agile or Scrum Master (especially for digital or hybrid project environments)
o Change Management (e.g. Prosci ACMP)

Experience
Minimum of 46 years of experience in manufacturing operations project management or continuous improvement within the pharmaceutical biotech or life sciences industry.
Minimum 2 years of hands-on experience applying Lean Six Sigma Agile or other structured improvement methodologies; certification (e.g. Green Belt Black Belt) preferred.
Minimum 2 years of experience managing integrated project schedules using tools such as Primavera P6 MS Project or equivalent with demonstrated ability to manage complex cross-functional timelines.
Experience with both Waterfall and Agile project management frameworks including familiarity with SDLC and Design Thinking principles.
Proven ability to manage schedules and streamline execution through proactive planning and risk mitigation.
Experience designing developing and implementing enterprise-wide initiatives or programs.
Solid understanding of GMP Lean Manufacturing Systems commissioning & qualification (C&Q) and regulatory requirements.
Demonstrated ability to lead change management and stakeholder engagement efforts across functions and geographies.
Proven track record of identifying improvement opportunities implementing sustainable solutions and fostering a culture of operational excellence.

Technical Skills
Integrated scheduling and milestone management
Critical path and dependency analysis
Risk identification and mitigation planning
Proficiency in Microsoft Office Suite including MS Project Excel and PowerPoint
Strong analytical problem-solving organizational and facilitation skills
Continuous improvement mindset focused on efficiency quality and sustainability

Non-Technical Skills
Results-oriented and able to navigate ambiguity you set clear outcomes track progress follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly take accountability and manage tasks efficiently. Adapt to change with clarity patience and understanding guiding teams through evolving challenges. Exhibit strong organizational skills attention to detail and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others perspectives fostering productive engaging interactions and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect integrity and humility prioritizing collective success over individual gain. Resourceful and proactive challenge the status quo drive innovation and develop creative solutions. Apply an enterprise-wide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

Must be able to work in an office and regulated manufacturing environment including construction/start-up phases with appropriate PPE. Reasonable accommodation will be provided as required by law.

This position is based on-site in Sanford NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a remote or hybrid role.

Requires up to 10% domestic and limited international travel.

The anticipated salary for this position will be $106700 to $145000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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