Sr Specialist, Quality Control-Microbiology

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 Sr Specialist, Quality Control Microbiology will play a critical role in the start-up, and operations of the Quality Control Microbiology Laboratory organization 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 provide technical leadership to the QC Microbiology 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 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.

Requirements

• Bachelor's degree in Microbiology, Biotechnology, or life sciences (minimum).
• Master's degree in Microbiology or related life science (preferred).
• At least 5 years of experience in Quality Control Microbiology laboratory.
• Experience leading and conducting investigation of Microbial contamination incidents.
• In-depth understanding of the QMS and Laboratory Controls subsystem.
• Experience with starting up and providing QC Microbiology expertise to a new facility is a plus.
• Experience reviewing and contributing to Engineering Plans and GxP documentation.
• Proficient in MS Office Suite, and Lean Labs or Agile Lean.

Responsibilities

• Provide technical and compliance leadership to business processes within QC Microbiology 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 microbiological methods.
• Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures.
• Establish a Site Risk Management procedure for documentation of risk-based approaches.
• Lead and coordinate the implementation of Site GxP procedures in support of Environmental and Utility Monitoring Program.
• Design and implement a site procedure for the investigation of Objectionable Microorganism.
• Train and qualify team members in the correct execution of Microbiology-related methods.
• Provide technical leadership to the facility and utility Environmental Monitoring Performance Qualification (EMPQ).
• Review and approve all required validation and qualification activities for the facility.
• Ensure compliance with current regulatory requirements for Data Integrity.
• Assist in onboarding, training, leading, and mentoring junior QC Microbiologists.
• Coordinate, schedule, and assign sampling and testing tasks.
• Establish key operational processes within the QC Microbiology 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, and laboratory exceptions.
• 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.

What This Job Offers

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