Manufacturing Operator III

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 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.

As a Manufacturing Operator III supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will play a key role in launching and executing core manufacturing operations:

• Serve as a role model for safety and GMP compliance.
• Execute complex upstream and downstream processes in a regulated environment.
• Participate in equipment commissioning, process validation, and automation implementation.
• Collaborate cross-functionally with Engineering, Automation, and Quality teams.
• Support troubleshooting and continuous improvement initiatives.
• Proactively identify, elevate, and respond to deviations, equipment issues, or process anomalies to ensure product quality and operational continuity.
• Train and mentor other manufacturing associates to build team capability.
• Contribute to the development of a high-performing, patient-centered manufacturing platform from the ground up.

As an individual contributor, you will take a compassionate and people-focused approach to your work, proactively collaborate with others to create a supportive and inclusive environment, and always act in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals.

Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports to the Manager, Manufacturing.

• Executes manufacturing operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production, including weigh and dispense, buffer and media preparation, bioreactors, filtration systems, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES systems.
• Ensures 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.
• Follows operational procedures and master batch records, adhering to both written and verbal instructions from supervisors. Maintains accurate and complete documentation, including batch records, logbooks, and other required records.
• Takes immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary to prevent impact to product quality or safety.
• Escalates all actual or perceived non-compliance events, safety concerns, or process deviations promptly and appropriately, ensuring timely resolution and documentation.
• Collaborates with Process Engineering, Automation, CQV, Quality, Operational Excellence (OPEX), and Warehouse teams to ensure compliant and efficient operations during commissioning and routine manufacturing.
• Contributes to the development of standard operating procedures (SOPs) and facilitates equipment validation and qualification in collaboration with engineering teams.
• Identifies and implements process improvements to optimize manufacturing operations. Leads or contributes to initiatives that streamline workflows, eliminate waste, and enhance productivity.
• Demonstrates working knowledge of enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.
• Leads on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues. Supports CAPA documentation and tracking.
• Maintains cleanliness and organization of the manufacturing area by performing routine cleaning and preventive maintenance in compliance with GMP and safety standards.
• Applies 5S, standard work, and Kanban principles to manage the shop floor. Coordinates with Warehouse and Maintenance teams to ensure availability of materials, supplies, and equipment for uninterrupted production.
• Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to ensure team competency and adherence to best practices.
• Assists in the technical transfer of new products and processes into the…