Senior Specialist, 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 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 Bioassay will play a critical role in the start-up, and operations of the QC Bioassay testing team within the new Kyowa Kirin North America monoclonal antibody drug substance manufacturing facility in Sanford, NC. This role will initially involve working in a greenfield environment and will transition to providing technical leadership to the QC Bioassay team throughout the GMP-ready, Tech Transfer, and facility licensure activities for the manufacturing of Phase III and early commercial products. Accountable to ensure compliance with 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 Bioassay testing 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).
* Advance knowledge and experience developing, qualifying, transferring, and performing Cell-based Bioassays, Immunoassays, analytical methods, and procedures following the established policies, Standard Operating Procedures, and Specifications in a GxP environment. Ex: Identity (ELISA), residual impurities (HCP by ELISA, DNA by qPCR), Protein Binding Analysis (by SPR), potency assay (by Cell-based Bioassay and ELISA), MMV, Mycoplasma, and In vitro-adventitious viruses, amongst others.
* Demonstrated ability to perform complex laboratory test methods as required to produce reliable, accurate and precise data in support of Drug Substance in-process and release testing.
* Expert-level knowledge and experience and working in tissue culture procedures, multiple cell-lines, aseptic techniques, contamination control, and the use of Bioanalytical and instruments such as: Spectrophotometer, pH meter, Plate washers, Plate readers, Biacore (SRP), Cell Viability Analyzers/Counters, Real-time qPCR, etc.
* Expertise on sampling, pipetting, system suitability, and analytical techniques for Bioassay method execution, 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 Bioassay operations and develop GxP training requirements for QC Staff.
* Establish a QC Bioassay 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.
* Leverage technical expertise to train and qualify team members in the correct execution of Cell-based functional Bioassays, and analytical-related methods on a variety of sample types (e.g.: Culture media, Validation samples, Raw Materials, In-process, DS release, Stability, investigation, etc.).
* Provide technical leadership to the procurement, installation and qualification of QC Bioassay lab equipment and analytical instruments to ensure facility readiness and to achieve production targets compliantly.
* Review and approve all required validation and qualification activities for the equipment, Bioanalytical instruments, and computerized systems required for project commissioning and operational readiness for start-up.
* Ensure compliance with current regulatory requirements for Data Integrity (ALCOA++) requirements as applicable to paper and electronic records (21 CFR Part 11).
* Assist Sr Manager by onboarding, training, leading, and mentoring junior QC Bioassay staff, cross-functional staff and/or contractors in QC Analytical topics as needed per approved staffing plans.
* Coordinate, schedule, and assign sampling and testing tasks. Review and approve QC Laboratory results.
* Establish key operational processes within the QC Analytical Lab including: Laboratory gowning requirements, personnel, and materials flow; sample receipt, processing, and disposal; Inventory management (i.e.: ordering, receiving, qualification, and release of critical lab supplies and consumables; Laboratory safety, Laboratory Waste management and disposal, Laboratory cleaning).
* Prepare laboratory reports and communicate results and findings to key stakeholders (e.g.: Bioanalytical Trends Report, excursion reports, OOS, Invalid Assays, etc.).
* Collaborate cross-functionally with the Operations and Quality Teams on ensuring alignment to global, regional policies and procedures.
* Collaborate with Quality Assurance and Quality Systems and Compliance on inspection readiness efforts and respond to compliance requests, findings, or concerns.
* Lead and ensure timely investigation of non-conformances, deviations, laboratory exceptions, or other cGMP issues at the site and initiate and communicate actions (CAPA) for diligent and effective resolution.
* Establish key performance indicators for Site Quality Metrics including Deviations, CAPAs, Change Controls, OOS, Invalid Assays, OOT, Equipment Failures, Bioanalytical Data trends, Stability Trends, Product Testing Turn-around-times, etc.).
* Provide subject matter expertise and leadership to establish a robust culture of quality based on patient-focus, sustainable compliance, and inspection-readiness for all GxP areas within the facility and laboratory areas.
* Develop, approve, monitor, and communicate progress against goals cross-functionally and to Site Leadership Team, and key stakeholders.
N/A

Education
* Bachelor's degree in Biology, Cell Biology, Immunology, Biochemistry, Biotechnology, or related life sciences (minimum)
Master's degree in life sciences (preferred)

Experience
* At least 5 years of experience in Quality Control Bioassay laboratory providing technical and compliance leadership within GxP Biopharmaceutical Manufacturing operations.
* Experience leading and conducting investigation of unexpected analytical results, Out of Trend results, deviations, laboratory nonconformances (OOS).
* In-depth understanding of the QMS and Laboratory Controls subsystem and relevant regulatory standards, as well as experience participating as a QC Bioanalytical SME during regulatory agency inspections of Bio-Pharmaceutical Manufacturing facilities and supporting areas.
* Experience with starting up and providing QC Bioanalytical lab expertise to a new (greenfield) facility is a plus. This includes facility design reviews, facility and equipment user requirements review, defining computerized systems requirements for the Manufacturing (MES/ERP/eBR/LIMS), Engineering (CMMS, eVAL, BMS), and laboratories (LIMS/ELN/LES).
* Experience reviewing and contributing to Engineering Plans and GxP documentation in support of the equipment, facilities, and processing qualification efforts (Validation protocols, reports, test plans, Project Verification Plans, Validation Master Plans, Site Master File, etc.).

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.
Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.

Work is 100% on-site. 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.

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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