Lead Quality Control Planner
The Lead Quality Control Planner will play a pivotal role in establishing and managing the Quality Control operations at Kyowa Kirin North America's new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position is integral to the startup phase and will provide technical leadership throughout GMP readiness, technology transfer, and facility licensure activities for Phase III and early commercial products. The role ensures compliance with current GxP standards and aligns with Kyowa Kirin's Quality Management System procedures.
Key responsibilities include coordinating and overseeing contracted laboratory services and staff, leading quality-focused projects from inception to completion, and collaborating with cross-functional teams such as Clinical Operations, Regulatory, and Manufacturing. The planner will manage project planning, resource allocation, scheduling, and risk assessment, while also developing and maintaining project dashboards, status reports, and issue logs. Additionally, the role involves authoring and approving standard operating procedures, policies, protocols, and technical reports, as well as providing training and mentorship to Quality Control analytical staff.
Candidates must possess a Bachelor's degree in Biotechnology or a related Life Science field, with a preference for a Master's degree. Required experience includes a minimum of 8 years in a Quality Control laboratory within GxP-regulated biopharmaceutical manufacturing operations for Bachelor's degree holders, or 5 years for those with a Master's degree. The role demands progressive experience in Quality Control, Quality Systems, and GMP compliance, including leadership of complex QC operations. Proficiency with Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), and Electronic Laboratory Notebooks (ELN) is preferred, along with advanced skills in Microsoft tools such as Excel, PowerPoint, Teams, SharePoint, and Project.
The anticipated salary for this position ranges from $129,000 to $193,500 annually. Kyowa Kirin North America offers a comprehensive benefits package, including a 401(k) plan with company matching, an annual bonus program, generous paid time off and holiday schedules, healthcare benefits covering medical, dental, prescription drugs, and vision, as well as health savings and flexible spending accounts. Additional benefits encompass well-being and work/life programs, long-term incentive programs, life and disability insurance, concierge services, pet insurance, tuition assistance, and employee referral awards.
Kyowa Kirin North America is a rapidly growing global specialty pharmaceutical company dedicated to discovering and delivering novel medicines in areas such as bone and mineral diseases, intractable hematologic conditions, hematology oncology, and rare diseases. The company emphasizes innovation, diversity, integrity, and collaboration, providing employees with opportunities for professional growth and the chance to make a meaningful impact on patient lives.