Senior Manufacturing Operator

Senior Manufacturing Operator

Sanford, NC

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.

Summary of Job

As a Senior Manufacturing Operator supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be tasked to start up and execute core manufacturing operations. You will be a role model for Safety and Compliance. You will execute complex upstream and downstream processes in a GMP environment, contribute to troubleshooting and continuous improvement efforts, ensure compliance with regulatory standards, and train and mentor other manufacturing associates.

Your role will be highly collaborative, working across Engineering, Automation, and Quality teams to help build a high-performing, patient-centered manufacturing platform from the ground up. This includes hands-on involvement in equipment commissioning, process validation, and the implementation of automated systems.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization's 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.

Essential Functions

Technical Skills, Knowledge, and Experience

• 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, current Good Manufacturing Practices (cGMP), and all other applicable requirements, including adherence to Data Integrity practices (ALCOA+).
• Adhere to operational procedures and master records and follow both written and verbal instructions from supervisors.
• 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.
• Ensure compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams.
• 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.
• Stay current on industry trends and technologies to drive innovation in production planning.
• Utilize enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.
• 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.
• Coordinate 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.

Job 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 with relevant Upstream operations, including:
• • Vial Thaw/Inoculation
  • Wave Bioreactors
  • Single-Use Bioreactors (50L, 500L, 3000L)
  • Harvest Operations
• Experience with relevant Downstream operations, including:
• • Chromatography
  • Viral Inactivation
  • Viral Filtration
  • TFF Systems
  • Bulk Filling
• Direct Upstream and Downstream GMP manufacturing experience required.
• Experience supporting 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 &