Specialist II, Quality Control-Analytical

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 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 Kirins 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 Kirins 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 organizations 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 Kirins 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
Bachelors degree in Chemistry Biochemistry Biotechnology or a related Life Sciences discipline required.
Advanced degree (Masters or Ph.D.) preferred.

Experience
Minimum of 2 to 4 years of experience in Quality Control Analytical Laboratory providing technical and compliance expertise within GxP Biopharmaceutical Manufacturing operations.
Experience with raw material testing.
Experience conducting investigation of unexpected analytical results out-of-trend results deviations laboratory nonconformances (OOS).
Understanding of the QMS and laboratory controls subsystem and relevant regulatory standards.
Experience with starting up and providing QC analytical laboratory expertise to a new (greenfield) facility is a plus.
Experience reviewing and contributing to Engineering Plans and GxP documentation in support of the equipment facilities and process qualification efforts (validation protocols reports test plans project verification plans validation master plans site master file etc.) 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 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.
Must be able to work in an office and regulated manufacturing environment including construction/start-up phases with appropriate PPE. 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% 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$81000 to $105800. 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:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

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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