Specialist II, Quality Control - Bioassay Laboratory

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, i