Manufacturing Operator III at KYOWA KIRIN INC

Sanford, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Apr, 26

Salary

42.0

Posted On

07 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Safety Compliance, GMP Compliance, Process Validation, Troubleshooting, Continuous Improvement, Technical Writing, Problem Solving, Critical Thinking, Lean Manufacturing, Collaboration, Training, Documentation, Equipment Operation, Data Integrity, Enterprise Systems, Process Optimization

Industry

Pharmaceutical Manufacturing

Description

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. • Participates 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, escalate, 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 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 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 manufacturing area. This role is an Individual contributor Education and Experience • Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) 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. Technical Skills • Hands-on experience with key unit operations including solution preparation, upstream and/or downstream processing, inoculation, and weigh & dispense activities. • Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work. • Experience in technical writing; ability to author and edit SOPs is a plus. • Proficient in Microsoft Office applications. • Strong problem-solving and critical thinking skills. • Working knowledge of MES, BMS, and PCS systems is a plus. • Maintains clean and compliant manufacturing environments in accordance with GMP and safety standards. • Skilled in reading and interpreting technical documents, troubleshooting issues, and operating production equipment. • Proficient in English, with the ability to perform basic math and statistical calculations. Non-Technical Skills • Results-oriented and able to navigate ambiguity. • Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives. • 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, engaging 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, prioritizing collective success over individual gain. • Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. • Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. • During construction and commissioning, this position will follow a Monday–Friday day shift schedule. 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 position 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 and move heavy objects such as material containers, bagged product, and pallets. Must also be able to stand for 3 or more hours while operating equipment. • Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law. • Requires up to 10% domestic and international travel. • This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role. • During the start-up phase, this role may require up to three months of training at our Japan manufacturing site, to be completed within the next two years. The anticipated salary for this position will be $40 pr/hr to $42 pr/hr. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: 401K with company matching Discretionary Profit Sharing Annual Bonus Program (Sales Bonus for Sales Jobs) Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) HSA & FSA Programs Well-Being and Work/Life Programs Long-Term Incentives Life & Disability Insurance Concierge Service Pet Insurance Tuition Assistance Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. Recruitment & Staffing Agencies Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-SH1

Responsibilities

The Manufacturing Operator III will execute complex upstream and downstream processes in a regulated environment and support troubleshooting and continuous improvement initiatives. This role also involves training and mentoring other manufacturing associates to build team capability.