Sr. Manager, Manufacturing Sciences and Technology

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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

Summary of Job:

The Senior Manager, Manufacturing Sciences and Technology (MS&T) will play a critical role in providing strategic direction and technical leadership for development, characterization, technical transfer, manufacturing and testing of clinical and commercial drug substance and drug product. The position requires a deep understanding of manufacturing processes and analytical methods to ensure monitoring, troubleshooting and continuous improvement at the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC.

This role will be involved in the transfer of Phase II, III and early commercial drug substance manufacturing from other Kyowa Kirin sites or Contract Manufacturing Organizations (CMOs). Working with internal and external teams to develop robust processes for manufacturing. This leader will possess a deep understanding of mAb drug substance manufacturing process and analytical methods to lead the transfer efforts for new and existing products.

As a people leader, you will embody compassionate, people-centric leadership to guide and support our team. You will collaborate closely with others, fostering a collaborative, inclusive, and supportive environment while driving team development. Your work will reflect the organization’s values and integrity in all your actions. Utilizing situational leadership and emotional intelligence, you will align diverse viewpoints, manage stakeholders, and make empathetic decisions to address individual and team needs effectively. You will also be results-oriented, ensuring that your team not only adapts to challenges but also delivers measurable outcomes that align with business objectives. Additionally, you will help teams navigate through change and uncertainty with resilience and clarity, enabling them to adapt to fast-evolving, rapidly scaling environments and meet new challenges in the biotech industry with a patient-focused mindset.

Essential Functions:

Technical Skills, Knowledge, and Experience

• Technical leadership: Providing technical knowledge, oversight and leadership for the development, characterization, and commercialization of mAb drug substances
• Process management: Leading the transfer of drug substance processes to and from the manufacturing facility and evaluating and optimizing processes to improve efficiency and quality
• Troubleshooting: Support investigation and troubleshooting following deviation related to manufacturing process and equipment. Support the implementation of Corrective actions following deviation.
• Change Control: perform impact assessment and collaborate with QA and MFG on establishment and execution of change action plan.
• Team management: Hiring, training, and developing a team of engineers and scientists
• Collaboration: Working with other departments, such as manufacturing, QA, QC, Supply chain, and process engineering to ensure processes are maintained and transferred effectively
• Documentation: Authoring and reviewing technical reports, process transfer summaries and other documents
• Compliance: Ensuring that changes to processes and methods are documented and carried out in compliance with cGMP requirements
• Presentations: Communicating project status to internal customers and suppliers

Leadership

• Results-Oriented: Lead teams by setting clear, measurable goals and ensuring accountability for achieving key objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within set timelines.
• Empathetic Communication: Listen carefully, give helpful feedback, and handle conflicts with care.
• Team Development: Mentor and guide team members, create growth plans, support ongoing learning, and develop the team with a patient-focused mindset.
• Inclusive Leadership: Build a diverse, respectful environment where everyone feels valued and supported.
• Supportive Environment: Encourage a positive workplace, celebrate achievements, and promote work-life balance.
• Collaboration: Lead by example, promote teamwork and respect, and ensure your actions reflect the organization’s values.
• Emotional Intelligence: Manage emotions thoughtfully, make empathetic decisions with a patient-focused mindset, and stay calm under pressure.
• Change Management: Help teams navigate change with clear communication and flexibility.
• Situational Leadership: Adapt your leadership style to meet the needs of the team, offering guidance or independence as needed, while keeping patient outcomes in mind.
• Stakeholder Management and Alignment Building: Work with different people to build alignment, guide discussions toward common goals, and ensure decisions are aligned with a patient-focused mindset.

Job Requirements:

Education

• MS or PhD in Pharmaceutical Sciences, Physical Sciences, Engineering or related Life Sciences is required. PhD preferred
• Experience with mAb drug substance transfer

Experience

• Minimum 5 years of experience in Manufacturing, Science, and Technology within the Pharmaceutical industry.
• Experience with Tech Transfer and Analytical Method Validation
• Demonstrated project management skills
• Demonstrated leadership and teamwork skills
• Excellent analytical and communication abilities
• Deep understanding of process validation concepts and experience with technical transfer in a GMP environment preferred

Technical Skills

• Proficient in MS Office Suite, statistics and designed experiments.

Non-Technical Skills

Demonstrate empathetic communication by actively listening and considering others’ perspectives to foster productive and engaging interactions, while managing relationships with kindness and care. Embrace personal growth through continuous learning and sharing knowledge, maintaining a growth mindset. Foster inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by acknowledging achievements and promoting healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Be resourceful and proactive in challenging the status quo, driving innovation, and developing creative solutions. Maintain a results-oriented approach by setting clear goals, tracking progress, and ensuring your actions consistently lead to measurable outcomes that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding the team through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic, while demonstrating cultural sensitivity and the ability to build alignment in a global environment. Maintain an enterprise-wide, holistic mindset, working beyond siloed thinking to drive cohesive, integrated solutions.

Physical demands: Work is 100% on-site in Sanford, NC. This is not a hybrid or remote role

Working Conditions: Requires up to 25% domestic and limited international travel

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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