Manager Manufacturing

Kyowa Kirin is a fastgrowing global specialty pharmaceutical company that applies stateoftheart biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japanbased 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 Manager Manufacturing will play a critical role in providing tactical direction and leadership for drug substance (DS) manufacturing at the new Kyowa Kirin North America monoclonal antibody (mAb) drug substance manufacturing facility in Sanford NC.

You will lead a process centric team of direct reports and support colleagues to execute the production plan communicate across Tiers and functions and identify issues and solve them at the right level.

During the startup phase of the facility you will provide leadership for our operational readiness program. You will work with all functional groups and our Tech Transfer Team to drive the program. You will provide project management leadership develop plans timelines dependencies procedures and implement curricula and learning plans. You will also be heavily involved with facility startup activities including digital systems equipment and process validations as well as DS tech transfer activities.

As a people leader you will embody compassionate peoplecentric 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 organizations 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 resultsoriented 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 fastevolving rapidly scaling environments and meet new challenges in the biotech industry with a patientfocused mindset.

This role reports into the Director Manufacturing

Technical Skills Knowledge and Experience
Program Management: Provide project and program management expertise during the initial design and construction phase of the project.
Process Management: Have a thorough understanding of manufacturing and its management via Standard Work.
Team Management: Hiring training and develop a team of technicians and engineers
Communication: Communicate KPIs and batch status at Tier meetings. Escalate issues that cannot be resolved within the process centric team.
Troubleshooting and Collaboration: Use the Continuous Improvement loop to identify related issues. Work with Process Engineers MS&T Maintenance and QA in the process centric team to resolve these issues.
Collaboration: Utilize Kaizen events to improve operational efficiency.
Equipment Maintenance and Management: Understand and be able to implement Lean Manufacturing principles such as TPM to maintain process equipment in a compliant manner.
Technical Leadership: Be the subject matter expert on the manufacturing process providing technical knowledge oversight and leadership for the manufacture of mAb DS.
Documentation: Author and review SOPs and Work Instructions to facilitate DS manufacturing.
Compliance: Ensuring that the facility is inspection ready every day via Gemba walks use of 5S and Standard Work.

Leadership
ResultsOriented: Lead teams by setting clear measurable goals and ensuring accountability for achieving key objectives. Align resources effectively remove obstacles and maintain focus on delivering highquality 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 patientfocused mindset.
Inclusive Leadership: Build a diverse respectful environment where everyone feels valued and supported.
Supportive Environment: Encourage a positive workplace celebrate achievements and promote worklife balance.
Collaboration: Lead by example promote teamwork and respect and ensure your actions reflect the organizations values.
Emotional Intelligence: Manage emotions thoughtfully make empathetic decisions with a patientfocused 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 patientfocused mindset.
Manufacturing Associates with potential for additional positions based on business needs.

Education
AS or BS in Physical Sciences Engineering or related Life Sciences is required.

Experience
Minimum 7 years of experience Associates degree OR minimum 5 years of experience Bachelors Degree.
Relevant pharmaceutical DS manufacturing experience preferred.
Experience with implementing Lean Manufacturing.
Demonstrated leadership and teamwork skills.
Excellent analytical and communication abilities.
Good understanding of process validation concepts and experience with technical transfer preferred.
Experience with starting up and operating a biopharma manufacturing facility is a plus.

Technical Skills
Proficient in MS Office Suite.
Proficient in statistics.
Proficiency with Document Management and Investigation generation (e.g. in Veeva) as well as Change Control.
Proficiency with ERP systems such as MS Dynamics 365 is a plus.

NonTechnical Skills
Resultsoriented 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 worklife 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 enterprisewide holistic mindset working beyond siloed thinking to deliver cohesive integrated solutions.

Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford NC.

Work is 100 onsite. This is not a hybrid or remote role.

Requires up to 10 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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