Manufacturing Operator 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 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 organizations 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.

Education and Experience
Bachelors 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 start-up and operation of biopharmaceutical manufacturing processes is a plus.

Technical Skills
Experience with core unit operations such as solution preparation inoculation and weigh & dispense.
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.
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.
Experience with authoring or editing SOPs is a plus.
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.

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 MondayFriday 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 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 site to be completed within the next two years.

The anticipated salary for this position will be$ to $. 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 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 Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers 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 Controllers 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 .

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.