Kyowa Kirin, Inc.- U.S.
Manufacturing Operator III
Kyowa Kirin, Inc.- U.S., Sanford, North Carolina, United States, 27330
Kyowa Kirin is a fast‑growing global specialty pharmaceutical company that applies state‑of‑the‑art biotechnologies to discover and deliver novel medicines in bone & mineral, intractable hematology, oncology, and rare disease. A Japan‑based company with headquarters in Princeton, NJ, and offices in California, North Carolina, and Mississauga, Ontario, we translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization.
Manufacturing Operator III – Greenfield Biopharmaceutical Site As an individual contributor supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will play a key role in launching and executing core manufacturing operations.
Serve as a role model for safety and GMP compliance, executing complex upstream and downstream processes in a regulated environment.
Participate in equipment commissioning, process validation, and automation implementation.
Collaborate cross‑functionally with Engineering, Automation, and Quality teams.
Support troubleshooting and continuous improvement initiatives.
Proactively identify, elevate, and respond to deviations, equipment issues, or process anomalies to ensure product quality and operational continuity.
Train and mentor other manufacturing associates to build team capability.
Contribute to building a high‑performing, patient‑centered manufacturing platform from the ground up.
Execute manufacturing operations for monoclonal antibody (mAb) production, including weigh and dispense, buffer and media preparation, bioreactors, filtration systems, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES systems.
Ensure all processes comply with Safety and Compliance policies, cGMP, Data Integrity principles (ALCOA+), and all applicable regulatory requirements.
Follow operational procedures and master batch records, maintaining accurate documentation.
Take immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary.
Escalate actual or perceived non‑compliance events, safety concerns, or process deviations promptly and appropriately, ensuring timely resolution and documentation.
Collaborate with Process Engineering, Automation, CQV, Quality, Operational Excellence (OPEX), and Warehouse teams during commissioning and routine manufacturing.
Contribute to SOP development and facilitate equipment validation and qualification with engineering teams.
Identify and implement process improvements to optimize manufacturing operations, streamline workflows, eliminate waste, and enhance productivity.
Demonstrate working knowledge of enterprise systems supporting manufacturing operations (ERP, LIMS, MES, PCS, QMS, BMS).
Lead on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues, supporting CAPA documentation and tracking.
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 to manage the shop floor; coordinate with Warehouse and Maintenance teams to ensure availability of materials, supplies, and equipment.
Assist 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) and at least 2 years of relevant biopharmaceutical manufacturing experience.
Associate degree in a technical field and at least 4 years of relevant experience.
High school diploma or equivalent and at least 6 years of experience.
Experience with start‑up and operation of biopharmaceutical manufacturing processes is strongly preferred.
Technical Skills
Hands‑on experience with key unit operations: solution preparation, upstream/downstream processing, inoculation, weigh & dispense.
Familiarity with Agile and Lean manufacturing principles, including Standard Work.
Experience in technical writing; ability to author and edit SOPs.
Proficiency in Microsoft Office.
Strong problem‑solving and critical‑thinking skills.
Working knowledge of MES, BMS, and PCS systems.
Maintain clean and compliant manufacturing environments in accordance with GMP and safety standards.
Skilled in reading and interpreting technical documents, troubleshooting issues, and operating production equipment.
Proficient in English with basic math and statistical calculation ability.
Non‑Technical Skills
Results‑oriented and adaptable to ambiguity.
Set clear outcomes, track progress, follow through on commitments, and ensure measurable results.
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 fostering cultural sensitivity.
Communicate with care by actively listening and considering others' perspectives.
Embrace personal growth through continuous learning and knowledge sharing.
Promote inclusive collaboration by respecting diverse perspectives.
Encourage a healthy work‑life balance and recognize achievements.
Work collaboratively with respect, integrity, and humility, prioritizing collective success.
Resourceful and proactive, challenging the status quo to drive innovation.
Apply an enterprise‑wide, holistic mindset beyond siloed thinking.
Shift details: Monday–Friday day shift during construction and commissioning; then 2‑2‑3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required.
Start‑up phase may require up to three months of training at our Japan manufacturing site, to be completed within the next two years.
Must lift up to 35 lb and stand for 3+ hours while operating equipment.
Must work in a regulated manufacturing environment, including construction/start‑up phases, with appropriate PPE. Reasonable accommodation provided as required by law.
Requires up to 10% domestic and international travel.
Position is based on‑site in Sanford, NC; this role is not hybrid or remote.
Compensation The anticipated salary for this position is
$40–$42 per hour ; the actual salary offered at commencement may vary based on experience, skill set, qualifications, and other factors.
Benefits
401(k) with company matching
Discretionary profit sharing
Annual bonus program
Generous PTO, holiday schedule (including summer and winter shutdowns, sick days, and volunteer days)
Healthcare benefits (medical, dental, prescription drugs, vision)
HSA & FSA programs
Well‑being and work/life programs
Long‑term incentives
Life & disability insurance
Concierge service
Pet insurance
Tuition assistance
Employee referral awards
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. Kyowa Kirin North America, Inc. provides 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.
Data Privacy When you apply to a job on this site, the personal data in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Dr., Princeton, NJ 08540, USA. The Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed to manage recruitment activities, including interviews and tests. Processing is lawful under Article 6(1)(f) of the GDPR. Personal data may be shared with Greenhouse Software, Inc. and transferred to the United States if you reside outside the EU. Data are retained for as long as necessary for recruitment and can be accessed, rectified, erased, or used for data portability upon request.
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Manufacturing Operator III – Greenfield Biopharmaceutical Site As an individual contributor supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will play a key role in launching and executing core manufacturing operations.
Serve as a role model for safety and GMP compliance, executing complex upstream and downstream processes in a regulated environment.
Participate in equipment commissioning, process validation, and automation implementation.
Collaborate cross‑functionally with Engineering, Automation, and Quality teams.
Support troubleshooting and continuous improvement initiatives.
Proactively identify, elevate, and respond to deviations, equipment issues, or process anomalies to ensure product quality and operational continuity.
Train and mentor other manufacturing associates to build team capability.
Contribute to building a high‑performing, patient‑centered manufacturing platform from the ground up.
Execute manufacturing operations for monoclonal antibody (mAb) production, including weigh and dispense, buffer and media preparation, bioreactors, filtration systems, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES systems.
Ensure all processes comply with Safety and Compliance policies, cGMP, Data Integrity principles (ALCOA+), and all applicable regulatory requirements.
Follow operational procedures and master batch records, maintaining accurate documentation.
Take immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary.
Escalate actual or perceived non‑compliance events, safety concerns, or process deviations promptly and appropriately, ensuring timely resolution and documentation.
Collaborate with Process Engineering, Automation, CQV, Quality, Operational Excellence (OPEX), and Warehouse teams during commissioning and routine manufacturing.
Contribute to SOP development and facilitate equipment validation and qualification with engineering teams.
Identify and implement process improvements to optimize manufacturing operations, streamline workflows, eliminate waste, and enhance productivity.
Demonstrate working knowledge of enterprise systems supporting manufacturing operations (ERP, LIMS, MES, PCS, QMS, BMS).
Lead on‑floor troubleshooting and resolution of equipment, automation, and process‑related issues, supporting CAPA documentation and tracking.
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 to manage the shop floor; coordinate with Warehouse and Maintenance teams to ensure availability of materials, supplies, and equipment.
Assist 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) and at least 2 years of relevant biopharmaceutical manufacturing experience.
Associate degree in a technical field and at least 4 years of relevant experience.
High school diploma or equivalent and at least 6 years of experience.
Experience with start‑up and operation of biopharmaceutical manufacturing processes is strongly preferred.
Technical Skills
Hands‑on experience with key unit operations: solution preparation, upstream/downstream processing, inoculation, weigh & dispense.
Familiarity with Agile and Lean manufacturing principles, including Standard Work.
Experience in technical writing; ability to author and edit SOPs.
Proficiency in Microsoft Office.
Strong problem‑solving and critical‑thinking skills.
Working knowledge of MES, BMS, and PCS systems.
Maintain clean and compliant manufacturing environments in accordance with GMP and safety standards.
Skilled in reading and interpreting technical documents, troubleshooting issues, and operating production equipment.
Proficient in English with basic math and statistical calculation ability.
Non‑Technical Skills
Results‑oriented and adaptable to ambiguity.
Set clear outcomes, track progress, follow through on commitments, and ensure measurable results.
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 fostering cultural sensitivity.
Communicate with care by actively listening and considering others' perspectives.
Embrace personal growth through continuous learning and knowledge sharing.
Promote inclusive collaboration by respecting diverse perspectives.
Encourage a healthy work‑life balance and recognize achievements.
Work collaboratively with respect, integrity, and humility, prioritizing collective success.
Resourceful and proactive, challenging the status quo to drive innovation.
Apply an enterprise‑wide, holistic mindset beyond siloed thinking.
Shift details: Monday–Friday day shift during construction and commissioning; then 2‑2‑3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required.
Start‑up phase may require up to three months of training at our Japan manufacturing site, to be completed within the next two years.
Must lift up to 35 lb and stand for 3+ hours while operating equipment.
Must work in a regulated manufacturing environment, including construction/start‑up phases, with appropriate PPE. Reasonable accommodation provided as required by law.
Requires up to 10% domestic and international travel.
Position is based on‑site in Sanford, NC; this role is not hybrid or remote.
Compensation The anticipated salary for this position is
$40–$42 per hour ; the actual salary offered at commencement may vary based on experience, skill set, qualifications, and other factors.
Benefits
401(k) with company matching
Discretionary profit sharing
Annual bonus program
Generous PTO, holiday schedule (including summer and winter shutdowns, sick days, and volunteer days)
Healthcare benefits (medical, dental, prescription drugs, vision)
HSA & FSA programs
Well‑being and work/life programs
Long‑term incentives
Life & disability insurance
Concierge service
Pet insurance
Tuition assistance
Employee referral awards
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. Kyowa Kirin North America, Inc. provides 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.
Data Privacy When you apply to a job on this site, the personal data in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), located at 510 Carnegie Center Dr., Princeton, NJ 08540, USA. The Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed to manage recruitment activities, including interviews and tests. Processing is lawful under Article 6(1)(f) of the GDPR. Personal data may be shared with Greenhouse Software, Inc. and transferred to the United States if you reside outside the EU. Data are retained for as long as necessary for recruitment and can be accessed, rectified, erased, or used for data portability upon request.
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