Kyowa Kirin is hiring a 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. 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 recoveries, excursion reports, OOS, and invalid assay documentation. - Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations. - Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing corrective and preventive actions (CAPAs). - Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times. - Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy. - Track progress against individual and team goals and communicate updates to the Site Leadership Team and key stakeholders. Subordinates: Individual Contributor with responsibility to lead or work with cross-functional project teams. Job Requirements: Education - Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required. - Master’s degree or graduate-level studies preferred. Experience - Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations. - Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards. - Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus. - Familiarity with engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is also preferred. Technical Skills - Proficient in MS Office Suite, and Lean Labs or Agile Lean. Non-Technical Skills - Results-oriented and able to navigate ambiguity. - Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives. - Respond promptly, take accountability, and manage tasks efficiently, and adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. - Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. - Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. - Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. - Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. - Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. - Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions. - Results-oriented and able to navigate ambiguity. - Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives and respond promptly, take accountability, and manage tasks efficiently. - Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges and exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. - Communicate with care by actively listening and considering others' perspectives, fostering productive, engaging interactions, and managing relationships with kindness. - Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. - Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. - Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.