Manufacturing Operator II

Kyowa Kirin North America•Sanford, NC

2d•Onsite

About The Position

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 II 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, including upstream and/or downstream operations. • Participate in equipment commissioning, process validation, and automation implementation activities. • Collaborate with Engineering, Automation, and Quality teams to support operational readiness. • Assist with troubleshooting and contribute to continuous improvement initiatives. • Ensure compliance with regulatory standards and adherence to established procedures. • Train and support other manufacturing associates to promote team development and operational consistency. • 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 • 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 equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES systems. • 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. • Collaborates with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to support compliant and efficient operations during commissioning and routine manufacturing. • Assists with equipment validation and qualification activities in coordination with engineering 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 through routine cleaning and preventive maintenance in 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. • Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to support team development and consistency. • Participate in the technical transfer of new products and processes into the manufacturing area. Individual contributor role.

Requirements

Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with relevant experience in biopharmaceutical manufacturing also preferred.
Associate degree in a technical field and at least 2 years of relevant experience in biopharmaceutical manufacturing.
High school diploma or equivalent and at least 4 years of relevant experience in biopharmaceutical manufacturing.
Experience with core unit operations such as solution preparation, inoculation, and weigh & dispense.
Basic technical writing skills, such as reviewing or editing SOPs.
Proficient in Microsoft Office applications (e.g., Word, Excel, Outlook).
Strong problem-solving and critical thinking abilities.
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 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.

Nice To Haves

Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.
Exposure to upstream and/or downstream bioprocessing operations is preferred.
Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work, is preferred.
Experience with authoring or editing SOPs is a plus.
Familiarity with MES, BMS, and PCS systems is preferred.

Responsibilities

Serve as a role model for safety and GMP compliance.
Execute biomanufacturing processes in a regulated environment, including upstream and/or downstream operations.
Participate in equipment commissioning, process validation, and automation implementation activities.
Collaborate with Engineering, Automation, and Quality teams to support operational readiness.
Assist with troubleshooting and contribute to continuous improvement initiatives.
Ensure compliance with regulatory standards and adherence to established procedures.
Train and support other manufacturing associates to promote team development and operational consistency.
Contribute to building a high-performing, patient-centered manufacturing platform from the ground up.
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 equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES systems.
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.
Collaborates with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to support compliant and efficient operations during commissioning and routine manufacturing.
Assists with equipment validation and qualification activities in coordination with engineering 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 through routine cleaning and preventive maintenance in 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.
Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to support team development and consistency.
Participate in the technical transfer of new products and processes into the manufacturing area.

Benefits

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 Incentive Program (subject to job level and performance)
Life & Disability Insurance
Concierge Service
Pet Insurance
Tuition Assistance
Employee Referral Awards