Sr Specialist, Quality Control-Analytical

Kyowa Kirin, Inc.- U.S. • Sanford, NC

302d • 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 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.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Biotechnology, or life sciences (minimum).
• At least 5 years of experience in Quality Control Analytical Laboratory providing technical and compliance leadership within GxP Biopharmaceutical Manufacturing operations.
• Experience leading and conducting investigation of unexpected analytical results.
• In-depth understanding of the QMS and Laboratory Controls subsystem and relevant regulatory standards.
• Experience with starting up and providing QC Analytical lab expertise to a new (greenfield) facility is a plus.
• Experience reviewing and contributing to Engineering Plans and GxP documentation.

Nice To Haves

• Master's degree in life science (preferred).
• Experience with facility design reviews and defining computerized systems requirements.

Responsibilities

• 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.
• Prioritize implementation of equipment, instruments and analytical methods required for facility start-up.
• Advance knowledge and experience qualifying, transferring, and performing compendial and non-routine analytical methods.
• Hands-on experience in analytical methods and associated analytical laboratory instruments.
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures.
• Establish a QC Analytical Risk Management procedure.
• Lead and coordinate the implementation of the required Site GxP procedures.
• Train and qualify team members in the correct execution of Chemistry, biochemistry, and analytical-related methods.
• Provide technical leadership to the procurement, installation and qualification of QC Analytical lab equipment.
• Review and approve all required validation and qualification activities for the facility.
• Ensure compliance with current regulatory requirements for Data Integrity.
• Assist Sr Manager by onboarding, training, leading, and mentoring junior QC Analytical 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.

Benefits

• Equal employment opportunity to all qualified persons.
• Opportunities for personal growth through continuous learning and knowledge sharing.

What This Job Offers

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