Manager, Solutions Prep

About the role

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.

Responsibilities

• Provide project and program management expertise during the initial design and construction phase of the project.
• Have a thorough understanding of manufacturing operations and their management through Standard Work.
• Provide technical leadership and operational support across multiple Drug Substance manufacturing functions, including Solutions/Buffer Preparation and Upstream Manufacturing.
• Maintain a working knowledge of upstream manufacturing processes, including cell culture, bioreactor operations, harvest activities, and process monitoring, sufficient to effectively support cross-functional manufacturing activities.
• Support operational decision-making and manufacturing execution for Upstream Manufacturing activities when required, including providing leadership support and cross-functional coverage as needed.
• Partner with Upstream Manufacturing, MS&T, Engineering, Maintenance, and Quality teams to ensure seamless manufacturing operations across Drug Substance functions.
• Deliver on Key Performance Indicators (KPIs) and communicate KPI and batch status at Tier meetings. Escalate issues that cannot be resolved.
• 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.
• Understand and implement Lean Manufacturing principles to maintain process equipment in a compliant manner.
• Serve as the subject matter expert on the manufacturing process, providing technical knowledge, oversight, and leadership for the manufacture of mAb Drug Substance (DS).
• Author and review Standard Operating Procedures (SOPs) and Work Instructions to facilitate DS manufacturing.
• 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.

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, leading, or collaborating with upstream biopharmaceutical manufacturing operations, 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.

Qualifications

• Technical Skills: Proficiency with ERP systems is a plus, 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.

Skills

• Leadership & Collaboration: Results-oriented, technical leadership, collaboration, communication, change management, stakeholder management and alignment building.

Benefits

• 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