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.

This Manufacturing Operator III role supports a greenfield biopharmaceutical site focused on rare disease therapies and plays a key role in launching and executing core manufacturing operations. The position is located in Sanford, NC, and reports directly to the Manager of Manufacturing.

• 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, escalated 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.
• Execute manufacturing operations in accordance with standard work, work instructions, SOPs, and batch records for monoclonal antibody (mAb) production.
• Maintain accurate documentation, including batch records, logbooks, and other required records.
• Take immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary.
• Escalate non‑compliance events, safety concerns, or process deviations promptly and appropriately.
• Collaborate with Process Engineering, Automation, CQV, Quality, Operational Excellence, and Warehouse teams during commissioning and routine manufacturing.
• Contribute to SOP development and facilitate equipment validation and qualification.
• Identify and implement process improvements to optimize manufacturing operations.
• Lead on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues.
• Support CAPA documentation and tracking.
• Maintain cleanliness and organization of the manufacturing area and perform routine cleaning and preventive maintenance.
• Apply 5S, standard work, and Kanban principles to manage the shop floor.
• Assist in the technical transfer of new products and processes into the manufacturing area.

• Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology) and at least 2 years of relevant experience in biopharmaceutical manufacturing.
• Associate degree in a technical field and at least 4 years of relevant experience in biopharmaceutical manufacturing.
• High school diploma or equivalent and at least 6 years of relevant experience in biopharmaceutical manufacturing.
• Experience with start‑up and operation of biopharmaceutical manufacturing processes is strongly preferred.

• Hands‑on experience with solution preparation, upstream and/or downstream processing, inoculation, weigh & dispense activities.
• Familiarity with Agile and Lean manufacturing principles, including Standard Work.
• Experience in technical writing and ability to author and edit SOPs.
• Proficiency in Microsoft Office.
• Strong problem‑solving and critical thinking skills.
• Working knowledge of MES, BMS, and PCS systems.
• Maintenance of clean and compliant manufacturing environments in accordance with GMP and safety standards.
• Skill in reading and interpreting technical documents, troubleshooting issues, and operating production equipment.
• Proficiency in English, with basic math and statistical calculation ability.

• Results‑oriented and able to navigate ambiguity.
• Set clear…