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.
The Specialist II, Quality Control Bioassay Laboratory contributes to the establishment and execution of bioassay 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 progresses through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.
You apply technical knowledge to routine and moderately complex bioassay tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing analytical 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 will work in a laboratory setting, and is essential to building a reliable, compliant, and science-driven QC Bioassay function that enables 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.
This role reports into the Senior Manager, Quality Control
Technical Skills, Knowledge, and Experience
• Perform routine and moderately complex tasks within the QC Bioassay scope, contributing to lab operations and business processes. Collaborate cross-functionally during early-stage site activities, including reviewing user requirements and implementing equipment, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).
• Execute and assist in the qualification and transfer of cell-based bioassays, immunoassays, and analytical methods in accordance with GxP standards, SOPs, and specifications. Techniques include ELISA (identity, potency), HCP by ELISA, DNA by qPCR, protein binding by SPR, MMV, mycoplasma, and in vitro adventitious virus testing.
• Apply working knowledge of tissue culture procedures, multiple cell lines, aseptic techniques, contamination control, and operation of bioanalytical instruments (e.g., spectrophotometer, pH meter, plate washers/readers, Biacore SPR, cell viability analyzers, real-time qPCR).
• Perform sampling, pipetting, system suitability checks, and method execution for bioassay testing. Interpret and report data in alignment with ALCOA++ principles and 21 CFR Part 11 requirements.
• 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 Bioassay Laboratory.
• Participate in Site Risk Management activities, documenting risk-based decisions using established methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.
• Train and qualify team members in the execution of cell-based bioassays and analytical methods across sample types (e.g., culture media, validation samples, raw materials, in-process, drug substance, stability, investigations).
• Assist with procurement, installation, and qualification of bioassay lab equipment and instruments to ensure readiness for GMP operations and production targets.
• Review validation and qualification documentation for bioanalytical 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.
• Execute stability testing activities in accordance with site requirements and quality standards.
• Prepare and contribute to laboratory reports, including bioanalytical trends, excursions, out-of-specification (OOS) results, and invalid assay documentation.
• Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Bioassay 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, bioanalytical trends, stability trends, and turnaround times.
• Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Bioassay 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 relevant stakeholders.
Individual contributor, with responsibility to lead or work with cross-functional project teams.
Education
• Bachelor’s degree in Biology, Cell Biology, Immunology, Biochemistry, 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 Bioassay laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.
• Hands-on experience with stability testing and execution of bioassay methods.
• Experience conducting investigations of unexpected analytical results, out-of-trend (OOT) data, deviations, and laboratory non-conformances (e.g., OOS).
• Solid understanding of Quality Management Systems (QMS), laboratory control subsystems, and applicable regulatory standards.
• Experience contributing to the start-up of a QC Bioanalytical laboratory in a greenfield facility is a plus.
• Experience reviewing and contributing to 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 a plus.
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.
• 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.
• 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.
• 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.
Initially working on a construction site and ultimately in a biotech manufacturing laboratory. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases.
During the construction and start-up phases, employees are required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other gear as defined by site safety protocols.
While working at our onsite corporate facility, employees are required to wear appropriate business attire aligned with our standard dress code.
If traveling to both sites, one would be prepared for both arrangements.
Reasonable accommodation will be provided as required by law.
This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.
Requires up to 10% of domestic and limited international travel. Travel to Japan may be required for training and qualification activities during the Analytical Method transfer process.
The anticipated salary for this position will be $81,000 to $105,800. 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:
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions
It is the policy of Kyowa Kirin North America, Inc. to provide 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 affection preference or citizenship status or any other category protected by law.
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