Manufacturing Operator

Overview

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.

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. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. 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.

Ethics and Compliance:
Kyowa Kirin NA and all of its employees have an obligation to act in accordance with the law and with integrity in all operations and interactions.

Location and schedule details:
This position is based on-site in Sanford, NC. During construction and commissioning, the role will follow a Monday–Friday day shift. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs. The role will begin on a construction site and transition to a fully operational biopharmaceutical manufacturing facility in Sanford, NC.

Must be able to lift up to 35 lbs, stand for 3+ hours, and work in a regulated environment with appropriate PPE. Travel up to 10% may be required. This is not a hybrid or remote role.

• 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.
• Participate in the technical transfer of new products and processes into the manufacturing area.

• Associate degree in a technical field with relevant experience in biopharmaceutical manufacturing is preferred.
• Bio Works 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.

• Hands-on experience with key unit operations including solution preparation, inoculation, and weigh & dispense.
• Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work, is preferred.
• Proficient in Microsoft Office applications (e.g., Word, Excel, Outlook).
• Strong problem-solving and critical thinking abilities.
• Familiarity with MES, BMS, and PCS systems is preferred.
• Maintains clean and compliant manufacturing environments in accordance with GMP and safety standards.
• Able to read and interpret technical documents, troubleshoot basic issues, and operate production equipment.
• Proficient in English, with the ability to perform basic math and statistical calculations.

• Results-oriented and able to navigate ambiguity.
• Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results.
• Respond promptly, take accountability, and manage tasks efficiently.
• Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.
• Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.
• Communicate with care by actively listening and considering others  perspectives, fostering productive interactions, and managing relationships with kindness.
• Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.
• Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.
• Contribute positively by recognizing achievements and encouraging a healthy work-life balance.
• Collaborate with respect, integrity, and humility,…