Kyowa Kirin, Inc.- U.S.
Manufacturing Operator II
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
About the Role
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.
Key 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.
Execute 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.
Perform all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+).
Follow operational procedures and master batch records; maintain accurate documentation, including batch records and logbooks.
Escalate any actual or perceived non‑compliance events, equipment issues, or process deviations promptly.
Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams during commissioning and routine manufacturing.
Assist with equipment validation and qualification activities.
Identify opportunities for process improvement and contribute to initiatives that enhance operational efficiency.
Demonstrate working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS.
Assist with on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues; support CAPA documentation as needed.
Maintain cleanliness and organization of the manufacturing area through routine cleaning and preventive maintenance in compliance with GMP and safety standards.
Apply 5S, standard work, and Kanban principles; coordinate with Warehouse and Maintenance teams to ensure availability of materials and equipment.
Train and mentor new team members in manufacturing processes, equipment operation, safety procedures, and company standards.
Participate in the technical transfer of new products and processes into the manufacturing area.
Qualifications
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.
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.
Experience with core unit operations such as solution preparation, inoculation, and weigh & dispense.
Exposure to upstream and/or downstream bioprocessing operations preferred.
Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work, preferred.
Basic technical writing skills (reviewing/editing SOPs) and proficiency in Microsoft Office applications (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 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.
Results‑oriented and able to navigate ambiguity; set clear outcomes, track progress, and ensure actions lead to measurable results.
Responsive, accountable, and efficient task manager.
Adaptable to change with clarity and patience; guides teams through evolving challenges.
Strong organizational skills, attention to detail, and a solid work ethic with cultural sensitivity.
Excellent communication skills – active listening, empathy, and respect for diverse perspectives.
Commitment to continuous learning and growth mindset.
Promotes inclusive collaboration and a welcoming work environment.
Resourceful, proactive, challenging the status quo and driving innovation.
Physical Requirements and Work Conditions
Must be able to lift up to 35 lbs and move heavy objects such as material containers, bagged product, and pallets.
Must 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; no hybrid or remote work.
During the start‑up phase, up to three months of training may be required at our Japan site within the next two years.
Shift schedule: Monday‑Friday day shift during construction and commissioning; transition to a 2‑2‑3 day shift (7:00 AM – 7:00 PM) once operational.
Compensation and Benefits The anticipated salary for this position will be
$____ to $____.
The actual salary offered at commencement may vary based on experience, skill set, education, and other factors.
Benefits include:
401(k) with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule (incl. Summer and Winter Shut‑Downs, Sick Days, Volunteer Days)
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
Well‑Being and Work/Life Programs
Long‑Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Pet Insurance
Tuition Assistance
Employee Referral Awards
Equal Employment Opportunity Statement 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, citizenship status or any other category protected by law.
Application Information Apply online at the Kyowa Kirin North America careers site. Please submit a current resume and cover letter. All applications will be handled confidentially in compliance with applicable privacy laws.
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Key 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.
Execute 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.
Perform all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+).
Follow operational procedures and master batch records; maintain accurate documentation, including batch records and logbooks.
Escalate any actual or perceived non‑compliance events, equipment issues, or process deviations promptly.
Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams during commissioning and routine manufacturing.
Assist with equipment validation and qualification activities.
Identify opportunities for process improvement and contribute to initiatives that enhance operational efficiency.
Demonstrate working knowledge of enterprise systems such as ERP, LIMS, MES, PCS, QMS, and BMS.
Assist with on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues; support CAPA documentation as needed.
Maintain cleanliness and organization of the manufacturing area through routine cleaning and preventive maintenance in compliance with GMP and safety standards.
Apply 5S, standard work, and Kanban principles; coordinate with Warehouse and Maintenance teams to ensure availability of materials and equipment.
Train and mentor new team members in manufacturing processes, equipment operation, safety procedures, and company standards.
Participate in the technical transfer of new products and processes into the manufacturing area.
Qualifications
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.
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.
Experience with core unit operations such as solution preparation, inoculation, and weigh & dispense.
Exposure to upstream and/or downstream bioprocessing operations preferred.
Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work, preferred.
Basic technical writing skills (reviewing/editing SOPs) and proficiency in Microsoft Office applications (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 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.
Results‑oriented and able to navigate ambiguity; set clear outcomes, track progress, and ensure actions lead to measurable results.
Responsive, accountable, and efficient task manager.
Adaptable to change with clarity and patience; guides teams through evolving challenges.
Strong organizational skills, attention to detail, and a solid work ethic with cultural sensitivity.
Excellent communication skills – active listening, empathy, and respect for diverse perspectives.
Commitment to continuous learning and growth mindset.
Promotes inclusive collaboration and a welcoming work environment.
Resourceful, proactive, challenging the status quo and driving innovation.
Physical Requirements and Work Conditions
Must be able to lift up to 35 lbs and move heavy objects such as material containers, bagged product, and pallets.
Must 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; no hybrid or remote work.
During the start‑up phase, up to three months of training may be required at our Japan site within the next two years.
Shift schedule: Monday‑Friday day shift during construction and commissioning; transition to a 2‑2‑3 day shift (7:00 AM – 7:00 PM) once operational.
Compensation and Benefits The anticipated salary for this position will be
$____ to $____.
The actual salary offered at commencement may vary based on experience, skill set, education, and other factors.
Benefits include:
401(k) with company matching
Discretionary Profit Sharing
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule (incl. Summer and Winter Shut‑Downs, Sick Days, Volunteer Days)
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
Well‑Being and Work/Life Programs
Long‑Term Incentive Program (subject to job level and performance)
Life & Disability Insurance
Pet Insurance
Tuition Assistance
Employee Referral Awards
Equal Employment Opportunity Statement 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, citizenship status or any other category protected by law.
Application Information Apply online at the Kyowa Kirin North America careers site. Please submit a current resume and cover letter. All applications will be handled confidentially in compliance with applicable privacy laws.
#J-18808-Ljbffr