Sr Specialist, Quality Control-Microbiology

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.

The Senior Specialist Quality Control Microbiology 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 to the Senior Manager, Quality Control

Essential Functions: 
•    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; 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 qualifying, transferring, and performing compendial and non-routine microbiological methods and procedures following the established policies, Standard Operating Procedures, Analytical Methods, and Specifications in a GxP environment. Examples:  Bioburden (TAMC/TYMC), Bacterial Endotoxins (LAL), Growth Promotion, Microbial Identification, rapid microbiological methods, among others.
•    Expertise on Sampling, Culturing, Microscopy, and Aseptic Techniques. 
•    Leverage global electronic QMS Structure in VEEVA to establish and maintain Site Quality Control procedures as applicable to stand up the  QC Microbiology operations and develop GxP training requirements for QC Staff.
•    Establish a Site 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 Environmental and Utility Monitoring Program and Contamination Control Strategy.
•    Design and implement a site procedure for the investigation of   Objectionable Microorganism. 
•    Leverage technical expertise to train and qualify team member members in the correct execution of Microbiology-related methods  on a variety of sample types (e.g., Validation samples, Water, Air, Gases, Raw Materials, Surfaces, In-process, DS release, Stability, investigation, among others).
•    Provide technical leadership to the facility and utility Environmental Monitoring Performance Qualification (EMPQ), to ensure facility readiness and to achieve production targets compliantly.
•    Review and approve all required validation and qualification activities for the facility, equipment, analytical 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 applicab