Summary of Job

The Manager, Solutions Prep will play a critical role in providing tactical direction and leadership for Drug Substance (DS) manufacturing at Kyowa Kirin North America's new monoclonal antibody (mAb) manufacturing facility in Sanford, North Carolina.

This role will lead manufacturing operations responsible for executing the production plan, driving operational excellence, communicating across functions, and resolving manufacturing issues through effective escalation and collaboration.

During the startup phase, the Manager, Solutions Prep will provide leadership for operational readiness activities, partnering closely with cross-functional teams and the Tech Transfer organization to develop project plans, timelines, procedures, training programs, and readiness strategies. The role will also support facility startup activities, including equipment qualification, process validation, digital systems implementation, and drug substance technology transfer.

This position requires strong technical expertise across Drug Substance manufacturing operations, including Solutions/Buffer Preparation and Upstream Manufacturing. The individual will be expected to provide operational support and coverage for Upstream Manufacturing activities and must possess sufficient upstream process knowledge to effectively support the Upstream Process Manager when needed.

The successful candidate will leverage strong technical leadership, collaboration, and problem-solving skills to support manufacturing operations, drive continuous improvement initiatives, and ensure operational readiness and execution in a fast-paced biopharmaceutical manufacturing environment.
Essential Functions
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 operations and their management through Standard Work.
• Drug Substance Manufacturing Leadership: Provide technical leadership and operational support across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing.
• Upstream Manufacturing Expertise: Maintain strong working knowledge of upstream manufacturing processes, including cell culture, seed train expansion, bioreactor operations, harvest activities, and process monitoring.
• Operational Support: Support operational decision-making and manufacturing execution for Upstream Manufacturing activities when required, including providing coverage for the Upstream Process Manager.
• Cross-Functional Collaboration: Partner with Upstream Manufacturing, MS&T, Engineering, Maintenance, and Quality teams to ensure seamless manufacturing operations across Drug Substance functions.
• KPIs and Communication: Deliver on KPIs and communicate KPI and batch status at Tier meetings. Escalate issues that cannot be resolved.
• Troubleshooting and Collaboration: Use the Continuous Improvement loop to identify related issues. Work with Process Engineers, MS&T, Maintenance, and QA to resolve these issues. Utilize Kaizen events to improve operational efficiency.
• Equipment Maintenance and Management: Understand and implement Lean Manufacturing principles to maintain process equipment in a compliant manner.
• Technical Leadership: Serve as the subject matter expert on the manufacturing process, providing technical knowledge, oversight, and leadership for the manufacture of mAb Drug Substance (DS).
• Documentation: Author and review SOPs and Work Instructions to facilitate DS manufacturing.
• Safety and Compliance: Ensure all processes are performed in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as all other applicable regulatory requirements. Ensure the facility is inspection-ready every day through Gemba walks, 5S practices, and Standard Work.

Leadership & Collaboration

• Results-Oriented: Set clear priorities and drive execution against key operational objectives. Align resources effectively, remove obstacles, and maintain focus on delivering high-quality results within established timelines.
• Technical Leadership: Provide technical guidance and manufacturing expertise across Drug Substance operations, including Solutions/Buffer Preparation and Upstream Manufacturing.
• Collaboration: Partner effectively with Manufacturing, MS&T, Engineering, Maintenance, and Quality to achieve operational goals and resolve issues.
• Communication: Communicate effectively across functions, provide timely updates, and escalate issues appropriately.
• Change Management: Support operational readiness, startup activities, and continuous improvement initiatives in a dynamic manufacturing environment.
• Stakeholder Management and Alignment Building: Work with diverse stakeholders to build alignment, guide discussions toward common goals, and ensure decisions support business and operational objectives

Job Requirements
Education

• Associate's degree or Bachelor's degree in Physical Sciences, Engineering, or a related Life Sciences field is required.

Experience

• Minimum 7 years of experience plus an Associate's degree OR minimum 5 years of experience plus a Bachelor's degree
• Relevant pharmaceutical Drug Substance (DS) manufacturing experience
• Experience in Solutions/Buffer Preparation manufacturing
• Experience supporting or leading upstream biopharmaceutical manufacturing operations
• Strong understanding of upstream manufacturing processes, including cell culture, seed train expansion, bioreactor operations, harvest activities, and process monitoring
• Experience working across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing
• Experience implementing Lean Manufacturing principles
• Demonstrated technical leadership, collaboration, and teamwork skills
• Excellent analytical and communication abilities
• Good understanding of process validation concepts and experience with technology transfer preferred
• Experience with automation systems and electronic batch records preferred
• Experience starting up and operating a biopharmaceutical manufacturing facility is a plus.

Technical Skills

• Proficiency with ERP systems is a plus
• Proficient in MS Office Suite
• Proficiency with Document Management and Investigation generation (e.g. in Veeva) as well as Change Control
• Working knowledge of upstream bioprocessing operations and associated manufacturing systems.

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 while 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 effectively across functions and collaborate with diverse stakeholders to achieve operational goals.

Embrace personal growth through continuous learning and knowledge sharing while maintaining a growth mindset. Promote collaboration by respecting diverse perspectives and building strong working relationships across departments.

Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Be 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
Physical Demands

• Initially working on a construction site and ultimately in a biopharmaceutical manufacturing facility in Sanford, NC.
• Work is 100% on-site in Sanford, NC. This is not a hybrid or remote position.

The anticipated salary for this position will be $125,000 to $155,000. 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 match
• 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
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• 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

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