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.

Summary of Job As a Senior Manufacturing Operator supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be tasked to start up and execute core manufacturing operations. You will be a role model for Safety and Compliance. You will execute complex upstream and downstream processes in a GMP environment, contribute to troubleshooting and continuous improvement efforts, ensure compliance with regulatory standards, and train and mentor other manufacturing associates.

Your role will be highly collaborative, working across Engineering, Automation, and Quality teams to help build a high-performing, patient-centered manufacturing platform from the ground up. This includes hands-on involvement in equipment commissioning, process validation, and the implementation of automated systems. As an individual contributor, you will take a compassionate and people-focused approach to your work.

You will proactively collaborate with others to create a supportive and inclusive environment, 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 Essential Functions Technical Skills, Knowledge, and Experience Execute manufacturing operations utilizing standard work on the manufacturing floor for mAb manufacturing, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES.

Requirements

, including adherence to Data Integrity practices (ALCOA+). Adhere to operational procedures and master records and follow both written and verbal instructions from supervisors. Maintain accurate records, including batch records, log sheets, and other required documentation.

Escalate any and all non-compliance events (perceived or actual) in a timely manner. Ensure compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams. Develop operational SOPs, participate in FATs, and facilitate equipment validation and qualification in conjunction with Engineering teams.

Identify and implement process improvements to optimize operations. Propose and lead initiatives to streamline workflows and eliminate waste. Stay current on industry trends and technologies to drive innovation in production planning.

Utilize enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS. Lead on-the-floor troubleshooting and resolution of equipment, automation, and process issues and support CAPA tracking and documentation.