Specialist II, Quality Control - Microbiology

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.

Requirements

, 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.

, 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.