Senior Manufacturing Operator

Kyowa Kirin•Sanford, NJ

9d•Onsite

About The Position

Kyowa Kirin is a global specialty pharmaceutical company focused on discovering and delivering medicines for bone and mineral, intractable hematologic, hematology oncology, and rare diseases. The Senior Manufacturing Operator will support startup and execution of core manufacturing operations at a greenfield biopharmaceutical site focused on rare disease therapies. This individual contributor role executes complex upstream and downstream processes in a GMP environment, serves as a role model for safety and compliance, supports troubleshooting and continuous improvement, and trains and mentors other manufacturing associates. The role involves close collaboration with Engineering, Automation, Quality, CQV, OPEX, Warehouse, and Maintenance teams to establish a high-performing manufacturing platform. Work includes equipment commissioning, process validation, implementation of automated systems, technical transfers, and production operations. The operator is expected to contribute to an inclusive, collaborative, patient-centered workplace, take ownership of assigned work, adapt to change, and pursue continuous learning and improvement. The position is initially scheduled Monday through Friday on day shift during construction and commissioning, then transitions to a 2-2-3 day-shift schedule from 7:00 AM to 7:00 PM during manufacturing operations. It is 100% onsite at a construction site and, ultimately, a biopharmaceutical manufacturing facility in Sanford, North Carolina. The role requires up to 10% domestic and international travel.

Requirements

Relevant direct experience in upstream and downstream GMP manufacturing.
One of the following experience and education combinations: bachelor’s degree plus at least 4 years of relevant biopharmaceutical manufacturing experience; associate degree plus at least 6 years; or high school diploma/GED plus at least 8 years.
Knowledge of Agile and Lean Manufacturing principles and Standard Work.
Proficiency with Microsoft Office applications.
Strong problem-solving and critical-thinking skills.
Ability to maintain clean manufacturing environments in accordance with GMP and safety standards.
Ability to read and interpret technical documents.
Ability to troubleshoot and operate production equipment.
Ability to perform basic math and statistics.
Strong written and verbal English communication skills.
Results-oriented approach, with the ability to navigate ambiguity and drive measurable outcomes.
Strong accountability, follow-through, organization, and attention to detail.
Adaptability and resilience in a rapidly changing environment.
Strong communication and interpersonal skills and ability to collaborate across diverse teams and perspectives.
Commitment to continuous learning, knowledge sharing, innovation, and process improvement.
Ability to build inclusive and supportive working relationships and prioritize collective success.
Ability to lift up to 35 pounds, move heavy objects, and stand for three or more hours while operating equipment.
Ability to comply with gowning and PPE requirements.

Nice To Haves

Bachelor’s degree in a technical field such as Chemical Engineering, Chemistry, Biology, or a related discipline.
Experience supporting startup and operation of a biopharmaceutical manufacturing process.
Experience with upstream operations including vial thaw/inoculation, Wave bioreactors, single-use bioreactors (50L, 500L, or 3000L), and harvest operations.
Experience with downstream operations including chromatography, viral inactivation, viral filtration, TFF systems, and bulk filling.
Experience authoring or editing SOPs.
Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems.

Responsibilities

Execute mAb manufacturing operations using standard work, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids through PCS and MES.
Perform processes in accordance with safety policies, cGMP, applicable requirements, and ALCOA+ data-integrity practices.
Follow operational procedures, master records, and supervisors’ written and verbal instructions.
Maintain accurate batch records, log sheets, and other required documentation.
Escalate perceived or actual non-compliance events promptly.
Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to support compliant and efficient commissioning and manufacturing operations.
Develop operational SOPs, participate in FATs, and facilitate equipment validation and qualification with Engineering teams.
Identify and implement process improvements; propose and lead initiatives to streamline workflows and eliminate waste.
Stay current on industry trends and technologies to support innovation in production planning.
Use enterprise systems that support manufacturing operations, including ERP, LIMS, MES, PCS, QMS, and BMS.
Lead on-floor troubleshooting and resolution of equipment, automation, and process issues; support CAPA tracking and documentation.
Maintain clean, organized manufacturing areas through routine cleaning and preventative maintenance.
Manage shop-floor activities using 5S, Standard Work, and Kanban methodologies.
Coordinate with Warehouse and Maintenance teams to maintain availability of materials, supplies, and equipment.
Train new colleagues and junior staff in manufacturing processes, equipment operation, safety procedures, and company standards.
Assist with technical transfer activities for new products and manufacturing processes.

Benefits

401(k) with company match
Annual bonus program
Generous paid time off and holiday schedule, including summer and winter shutdowns
Sick days
Volunteer days
Healthcare benefits including medical, dental, prescription drug, and vision coverage
HSA and FSA programs
Well-being and work/life programs
Life and disability insurance
Concierge services
Long-term incentive program, subject to job level and performance
Pet insurance
Tuition assistance
Employee referral awards