Specialist II, Quality Control-Analytical

Specialist II, Quality Control-Analytical

Sanford, NC

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 Analytical will play a key role in establishing and operating the QC Analytical Laboratory at Kyowa Kirin's new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves into supporting GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.

You are responsible for providing technical expertise across QC Analytical operations and ensuring alignment with current GxP standards, as well as compliance with global, regional, and site-specific procedures within Kyowa Kirin's Quality Management System. This position is critical to building a compliant, efficient, and science-driven QC 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.

This role reports into the Senior Manager, Quality Control.

Technical Skills, Knowledge, and Experience

• Execute routine QC analytical tasks and contribute to lab operations during facility start-up, GMP readiness, and licensure activities. Participate in cross-functional efforts to review user requirements and implement lab equipment, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES, Empower).
• Perform and assist in the qualification and transfer of compendial and non-routine analytical methods in accordance with GxP standards, SOPs, and specifications. Techniques include identity, purity, protein concentration, appearance, assay, impurities, potency, titer, conductivity, and osmolarity.
• Conduct sampling, system suitability assessments, and analytical testing to enable assay integration, data interpretation, and reporting. Apply working knowledge of ALCOA++ principles and 21 CFR Part 11 to ensure data integrity and compliance during method execution and result review.
• Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS). Assist in configuring workflows to meet global, regional, and site-specific standards.
• Participate in Site Risk Management activities by documenting risk-based decisions using established methodologies and supporting rationale. Collaborate with peers to apply risk principles in daily QC operations.
• Implement Site GxP procedures for facility, utility, and raw material testing and monitoring programs in coordination with cross-functional teams.
• Train and qualify peers and junior team members in chemistry, biochemistry, and analytical methods across sample types (e.g., validation samples, water, cleaning, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).
• Assist with procurement, installation, and qualification of analytical instruments and lab equipment to ensure readiness for GMP operations and production targets.
• Review validation and qualification documentation for facility systems, 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 raw material qualification and testing in accordance with site requirements and quality standards.
• Prepare and contribute to laboratory reports, including analytical trends, excursions, out-of-specification (OOS) results, and invalid assay documentation.
• Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Analytical 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, analytical trends, and turnaround times.
• Demonstrate ownership of assigned tasks and contribute technical input to build a science-driven, compliant QC 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.

Education

Experience

Technical Skills

Proficient in MS Office Suite, and Lean Labs or Agile Lean.

Non-Technical Skills

Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your 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. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.

Benefits

Travel

Requires up to 10% domestic and limited international travel. Travel to Japan may be required for training and qualification activities during the Analytical Method transfer process.

Compensation

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).

Equal Employment Opportunity

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. When you apply to a job, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller") and processed for the purposes of managing recruitment and hiring activities.

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