Sr Specialist, 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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

The Senior Specialist, Quality Control Analytical will play a critical role in the start-up, and operations of the QC Analytical Laboratory organization within the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will initially be involved working in a greenfield environment and will transition to provide technical leadership to the QC Analytical organization throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and early commercial products. Accountable to ensure compliance of the Quality Control and Manufacturing operations with current GxP Standards and with all applicable Global, Regional and Site procedures within Kyowa Kirin’s Quality Management System.

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 
•    Provide technical and compliance leadership to business processes within the QC Analytical scope of responsibilities. Collaborate cross-functionally in the site early-stage activities, including identification and review of user requirements; prioritization for implementation of equipment, instruments and analytical methods required for facility start-up and selected electronic Quality Systems for operation (LIMS/ELN/LES/Empower).
•    Advance knowledge and experience qualifying, transferring, and performing compendial and non-routine analytical methods and procedures following the established policies, Standard Operating Procedures, and Specifications in a GxP environment. Ex: Identity, purity, Protein concentration, appearance, assay, impurities, potency, titer, conductivity osmolarity, among others. 
•    Hands-on experience in analytical methods and associated analytical laboratory instruments such as:  HPLC, GC, Spectrophotometry analyses,  pH, Conductivity, TOC, Calorimetry, Polarimetry, RAMAN, Refractometry, Densitometer, ELISA, PCR, Karl Fisher, Osmometer, among others.
•    Expertise on sampling, system suitability, and analytical techniques for assay integration and data interpretation and reporting.
•    Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures as applicable to stand up the  QC Analytical operations and develop GxP training requirements for QC Staff.
•    Establish a QC Analytical Risk Management procedure seeking to ensure a consistently robust and compliant methodology is implemented for the documentation of risk-based approaches and decisions based on sound rationales, with justifications supported by facts and data.
•    Lead and coordinate cross-functionally the robust and compliant and timely implementation of the required Site GxP procedures in support of the facility, utility and incoming raw materials testing and monitoring program. 
•    Leverage technical expertise to train and qualify team member members in the correct execution of Chemistry, biochemistry, and analytical-related methods  on a variety of sample types (e.g.: Validation samples, Water, Cleaning, Air, Gases, Raw Materials, Surfaces, In-process, DS release, Stability, investigation, among others).
•    Provide technical leadership to the procurement, installation and qualification of QC Analytical lab equipment and analytical instruments to ensure facility readiness and to achieve production targets compliantly.
•    Review and approve all required validation and qualification activities f