Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.

Summary:

As a Warehouse Associate III this individual operates all aspects of the Warehousing function at the Sanford Site. Initially the role will be focused on establishing all necessary elements of the Warehouse operations including: Support warehouse layout and capacity planning by providing operational input on storage locations, material flow, space utilization, and day-to-day warehouse requirements, as well as developing SOPs and related documents. All work will ensure the safe, compliant, and efficient movement of pharmaceutical products and raw materials within the heavily regulated warehouse environment. This role is responsible for receiving, storing, picking, packing, and shipping materials while adhering to strict regulatory requirements, including FDA, cGMP, GDP, and company SOPs. Inventory management and cycle counting as well as training are also responsibilities of the role. The Warehouse Associate will maintain inventory accuracy, ensure product integrity, along with developing and supporting warehouse process flows.

Key Responsibilities:

Receiving & Inventory Management • Utilizing material handling equipment, receive incoming raw materials, components, and finished goods; verify accuracy against purchase orders and shipping documents; and properly allocate for storage. • Inspect incoming materials for damage, correct labeling, and compliance with specifications. • Accurately record inventory transactions in warehouse management systems (ERP). Microsoft Dynamics D365 experience is a plus. • Maintain organized storage areas according to GxP, FEFO/FIFO, temperature controlled, and safety guidelines.

Picking, Packing & Shipping • Pick and stage materials for production and customer orders following established SOPs. • Package products securely to maintain product integrity and meet quality standards, inclusive of handling Haz Mat materials such as dry ice. • Prepare shipping documentation (e.g., packing slips, waybills, BOL). • Coordinate with carriers to schedule inbound and outbound shipments.

Regulatory Compliance & Documentation • Follow all FDA, cGMP, GDP, OSHA, and company-specific compliance requirements. • Complete all required logs, forms, and electronic records accurately and in real time. • Support internal and external audits through proper documentation and workspace organization.

Material Handling & Equipment • Safely operate all material-handling equipment such as pallet jacks, forklifts, reach trucks, pallet converter, shrink wrapper and order pickers (with proper certification). • Ensure equipment is maintained in safe working condition reporting any issues promptly, overseeing the equipment maintenance program. • Manage temperature controlled materials, including monitoring and documenting environmental conditions.

General Warehouse Operations • Maintain clean and hazard-free work areas in accordance with facility safety standards. • Participate in SKU layout, storage slotting, and rack labeling decisions. • Conduct cycle counts and full physical inventory activities for inventory reconciliation compliance. • Collaborate with cross-functional teams including Quality, Manufacturing, Finance and Global Supply Chain. • Support continuous improvement initiatives, troubleshooting to enhance warehouse efficiency and compliance. • Serve as a role model for safety and GxP compliance. • Collaborate with Engineering, Automation, and Quality teams to support operational readiness. • Ensure compliance with regulatory standards and adherence to established procedures.

Essential Functions:

• Executes warehouse operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production. • 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. • Escalates any actual or perceived non-compliance events, equipment issues, or process deviations in a timely and appropriate manner. • Identifies opportunities for process improvement and contributes to initiatives that enhance operational efficiency and reduce waste and demonstrates working knowledge of enterprise systems such as ERP, MES, PCS, QMS, and BMS. • Maintains cleanliness and organization of the warehouse area through routine cleaning and preventive maintenance in compliance with GMP and safety standards. • Trains and mentors new team members in warehouse processes, equipment operation, safety procedures, and company standards to support team development and consistency.

Requirements:

Education and Experience • Bachelor’s degree in a technical or scientific discipline (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 warehousing. • High school diploma or equivalent and at least 4 years of relevant direct experience in pharma/biopharma warehousing. • Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus. • 4–5 years of warehouse or distribution experience; pharmaceutical, medical device, or other regulated industry preferred.

Technical Skills • Basic technical writing skills, such as reviewing or editing SOPs. • Forklift certification and Experience with temperature controlled and/or hazardous materials. • Prior experience in a pharmaceutical manufacturing or distribution facility. • Proficient in Microsoft Office applications (e.g., Word, Excel, Outlook). • Strong problem-solving and critical thinking abilities. • Experience with authoring or editing SOPs is a plus. • Familiarity with ERP, MES, BMS, and PCS systems is preferred. • Maintains clean and compliant warehouse environments in accordance with GMP and safety standards and demonstrates the ability 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.

Physical Demands:

• This position will follow a Monday–Friday; 8-hour day shift schedule. Shift flexibility may be required during production runs and as needed based on production schedules. • The role will begin at our Sanford construction site and transition to a fully operational biopharmaceutical manufacturing facility in Sanford, NC. • Must be able to safely lift up to 35 lbs. and move heavy objects such as material containers, bagged product, and pallets. Must be able to bend, stoop, navigate operational spaces.

Must be able to stand for 3 or more hours while operating equipment. This role must seek assistance for all loads that are heavy or awkward and use mechanical devices whenever available. In this role, you should not lift more than 50 pounds without assistance. • 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

Working Conditions:

• May travel up to 5% 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.

The anticipated salary for this position will be $32.45/hr to $36.06/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
• 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

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 [email protected]. Controller’s data protection officer can be contacted at [email protected]. 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 [email protected].

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-TT1 #Sanford # North Carolina #Non-exempt #On-site