Warehouse Associate II

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 Warehouse Associate II, this individual supports the safe, compliant, and efficient movement of pharmaceutical products and raw materials within the warehouse environment. This role is responsible for receiving, storing, picking, packing, and shipping materials while adhering to strict regulatory requirements, including FDA, cGMP, and company SOPs. The Warehouse Associate plays a key role in maintaining inventory accuracy, ensuring product integrity, and supporting overall warehouse operations.

Key Responsibilities:

• Receiving & Inventory Management • Receive incoming raw materials, components, and finished goods; verify accuracy against purchase orders and shipping documents. • Inspect incoming materials for damage, correct labeling, and compliance with specifications. • Accurately record inventory transactions in warehouse management systems (ERP). D365 experience is a plus. • Maintain organized storage areas according to cGMP, FEFO/FIFO, 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. • Prepare shipping documentation (e.g., packing slips, waybills, BOL). • Coordinate with carriers to schedule and support outbound shipments.

• Regulatory Compliance & Documentation • Follow all FDA, cGMP, 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 • Operate material-handling equipment such as pallet jacks, forklifts, reach trucks, or order pickers (with proper certification). • Ensure equipment is maintained in safe working condition and report any issues promptly. • 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 cycle counts and full physical inventory activities. • Collaborate with cross-functional teams including Quality, Manufacturing, and Supply Chain. • Support continuous improvement initiatives to enhance warehouse efficiency and compliance. • Serve as a role model for safety and GMP compliance. • 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.

Job Requirements:

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.

Reporting Structure:

This role reports to the Director, Manufacturing.

Responsibilities:

• 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.

Education and Experience:

• 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 warehousing.
• High school diploma or equivalent and at least 4 years of relevant experience in warehousing.
• Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.
• 3-5 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.

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.

Work Environment:

• 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 role will begin on a 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.

Travel Requirements:

• Requires up to 10% domestic and international travel.

Salary and Benefits:

The anticipated salary for this position will be $25 per hour to $37.50 per hour. 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.

Equal Employment Opportunity:

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.

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