Manufacturing Operator I

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 I supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will play a key role in the start-up and execution of core manufacturing operations: 

•    Serve as a role model for safety and GMP compliance.
•    Execute biomanufacturing processes in a regulated environment.
•    Participate in equipment commissioning, process validation, and automation activities.
•    Collaborate cross-functionally with Engineering, Automation, and Quality teams.
•    Assist with troubleshooting and contribute to continuous improvement initiatives.
•    Ensure compliance with regulatory standards and adherence to established procedures.
•    Contribute to building 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 acting 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 into the Manager, Manufacturing

Technical Skills, Knowledge, and Experience 
•    Executes manufacturing operations utilizing standard work on the manufacturing floor for monoclonal antibodies (mAb) manufacturing including weigh and dispense, buffer and media prep, bioreactors, filtration equipment, inoculum preparation, chromatography skids and/or UF/DF skids via PCS and MES.
•    Performs all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as other applicable regulatory requirements. 
•    Follows operational procedures and master batch records; adheres to written and verbal instructions from supervisors. Maintains accurate documentation, including batch records, logbooks, and other required records. 
•    Escalates any actual or perceived non-compliance events, equipment issues, or process deviations in a timely and appropriate manner. 
•    Ensures compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX and Warehouse teams. 
•    Identifies opportunities for process improvement and contributes to initiatives that enhance operational efficiency and reduce waste. 
•    Demonstrates working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS. 
•    Assists with on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues; supports CAPA documentation as needed. 
•    Maintains cleanliness and organization of the manufacturing area by executing routine cleaning and preventative maintenance to ensure compliance with GMP and safety standards.
•    Applies 5S, standard work, and Kanban principles to maintain an organized and efficient shop floor. Coordinates with Warehouse and Maintenance teams to ensure availability of materials and equipment. 
•    Participate in the technical transfer of new products and processes into the manufacturing area.

This role is an Individual contributor

Education and Experience
•    Associate degree in a technical field with relevant experience in biopharmaceutical manufacturing is preferred. 
•    BioWorks certificate is preferred. 
•    High school diploma or equivalent and at least 2 years of relevant experience in biopharmaceutical manufacturing. 
•    Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.

Technical Skills
•    Hands-on experienc