Specialist II, Quality Control - Microbiology

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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: The Specialist II, Quality Control Microbiology plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin's new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products. You apply technical knowledge to routine and moderately complex microbiological tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing microbiological methods, maintaining compliance with current GxP standards, and ensuring alignment with global, regional, and site-specific procedures within Kyowa Kirin's Quality Management System. This role is essential to building a reliable, compliant, and science-driven QC Microbiology function that supports the broader manufacturing and quality strategy. 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. Reporting Relationship: Senior Manager, Quality Control Essential Functions: Technical Skills, Knowledge, and Experience: Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes. Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES). Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods. Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations). Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Microbiology Laboratory. Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations. Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams. Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans. Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals. Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness. Coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision. Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures. Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recover

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