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 & 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 
•    Bachelor’s degree in Engineering (Chemical, Biomedical, Process, Industrial), Life Sciences (Biotechnology, Biology, Chemistry, Pharmaceutical Sciences), Business Administration, or Operations Management 
•    Master’s 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 4–6 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 $106,700 to $145,000.  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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

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.

#LI-SH1