Senior Manufacturing Operator

About the role

Supports a greenfield biopharmaceutical site focused on rare disease therapies. Tasks include starting up and executing core manufacturing operations, ensuring compliance with regulatory standards, training and mentoring other manufacturing associates, and collaborating with engineering, automation, and quality teams.

Responsibilities

• Execute manufacturing operations utilizing standard work on the manufacturing floor for mAb manufacturing, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES.
• Ensure all processes are performed according to Safety and Compliance policies and procedures, cGMP, and all other applicable requirements, including adherence to Data Integrity practices (ALCOA+).
• Maintain accurate records, including batch records, log sheets, and other required documentation.
• Escalate any and all non-compliance events (perceived or actual) in a timely manner.
• Develop operational SOPs, participate in FATs, and facilitate equipment validation and qualification in conjunction with Engineering teams.
• Identify and implement process improvements to optimize operations.
• Propose and lead initiatives to streamline workflows and eliminate waste.
• Lead on-the-floor troubleshooting and resolution of equipment, automation, and process issues and support CAPA tracking and documentation.
• Maintain cleanliness and organization of manufacturing areas through routine cleaning and preventative maintenance.
• Manage shop floor activities through 5S, Standard Work, and Kanban methodologies.
• Cook up with Warehouse and Maintenance teams to ensure uninterrupted availability of materials, supplies, and equipment.
• Train new colleagues and junior staff in manufacturing processes, equipment operation, safety procedures, and company standards.
• Assist during technical transfer activities for new products and manufacturing processes.

Requirements

• Education: Bachelor's degree in a technical field (Chemical Engineering, Chemistry, Biology, or related discipline) preferred.
• Experience: Bachelor's degree plus a minimum of 4 years of relevant biopharmaceutical manufacturing experience; OR Associate's degree plus a minimum of 6 years of relevant biopharmaceutical manufacturing experience; OR High School Diploma/GED plus a minimum of 8 years of relevant biopharmaceutical manufacturing experience.
• Experience: Relevant Upstream operations, including Vial Thaw/Inoculation, Wave Bioreactors, Single-Use Bioreactors (50L, 500L, 3000L), Harvest Operations; Relevant Downstream operations, including Chromatography, Viral Inactivation, Viral Filtration, TFF Systems, Bulk Filling; Direct Upstream and Downstream GMP manufacturing experience required; Startup and operation of a biopharmaceutical manufacturing process preferred.
• Technical Skills: Knowledge of Agile and Lean Manufacturing principles and Standard Work; Proficiency with Microsoft Office applications; Strong problem-solving and critical-thinking skills; Experience authoring or editing SOPs preferred; Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems preferred; 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.
• Non-Technical Skills: Results-oriented with the ability to navigate ambiguity and drive measurable outcomes; Strong accountability and follow-through on commitments; Adaptability and resilience in a rapidly changing environment; Excellent organizational skills and attention to detail; Strong communication and interpersonal skills; Ability to foster collaboration across diverse teams and perspectives; Commitment to continuous learning and knowledge sharing; Growth mindset with a focus on innovation and process improvement; Ability to build inclusive and supportive working relationships; Enterprise mindset that prioritizes collective success and integrated solutions.

Physical Demands

• Initial schedule will be Monday–Friday Day Shift during construction and commissioning.
• Position will transition to a 2-2-3 Day Shift schedule (7:00 AM – 7:00 PM) during manufacturing operations.
• Initially working on a construction site and ultimately in a biopharmaceutical manufacturing facility in Sanford, NC.
• Ability to lift up to 35 pounds and move heavy objects.
• Ability to stand for three or more hours while operating equipment.
• Must adhere to gowning and PPE requirements.
• Position is 100% on-site and is not eligible for remote or hybrid work.
• Requires up to 10% domestic and international travel.

Compensation & Benefits

The anticipated salary for this position will be $33.00 to $45.00 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:

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance

Equal Employment Opportunity

Kyowa Kirin North America, Inc. is committed to providing 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 affectional preference, citizenship status, or any other category protected by law.

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