Senior Specialist, Quality Control-Bioassay Laboratory

Kyowa Kirin, Inc.- U.S. • Sanford, NC

311d • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Biology, Cell Biology, Immunology, Biochemistry, Biotechnology, or related life sciences (minimum).
• Master's degree in life sciences (preferred).
• 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.
• Experience participating as a QC Bioanalytical SME during regulatory agency inspections.
• Experience with starting up and providing QC Bioanalytical lab expertise to a new (greenfield) facility is a plus.
• Experience reviewing and contributing to Engineering Plans and GxP documentation.

Nice To Haves

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

Responsibilities

• 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.
• Prioritize implementation of equipment, instruments and analytical methods required for facility start-up and selected electronic Quality Systems for operation.
• Advance knowledge and experience developing, qualifying, transferring, and performing Cell-based Bioassays, Immunoassays, analytical methods, and procedures following established policies.
• Demonstrated ability to perform complex laboratory test methods to produce reliable, accurate and precise data in support of Drug Substance in-process and release testing.
• Expert-level knowledge and experience in tissue culture procedures, multiple cell-lines, aseptic techniques, contamination control, and the use of Bioanalytical instruments.
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures.
• Establish a QC Bioassay Risk Management procedure to ensure a robust and compliant methodology.
• Train and qualify team members in the correct execution of Cell-based functional Bioassays and analytical-related methods.
• Provide technical leadership to the procurement, installation and qualification of QC Bioassay lab equipment.
• Review and approve all required validation and qualification activities for the equipment and Bioanalytical instruments.
• Ensure compliance with current regulatory requirements for Data Integrity.
• Assist Sr Manager by onboarding, training, leading, and mentoring junior QC Bioassay staff.
• Coordinate, schedule, and assign sampling and testing tasks.
• Establish key operational processes within the QC Analytical Lab.
• Prepare laboratory reports and communicate results and findings to key stakeholders.
• Collaborate cross-functionally with the Operations and Quality Teams.
• Lead and ensure timely investigation of non-conformances, deviations, laboratory exceptions, or other cGMP issues.
• Establish key performance indicators for Site Quality Metrics.
• Provide subject matter expertise and leadership to establish a robust culture of quality.
• Develop, approve, monitor, and communicate progress against goals cross-functionally.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree