Senior QC Microbiology Lead – Start-up Facility

Kyowa Kirin, Inc.- U.S.; Sanford (NC); On-site; USD 116,000 - 152,000; Full time

Job summary

Kyowa Kirin, Inc. in Sanford, NC is seeking a Senior/Sr Specialist Quality Control Microbiology to lead the QC Microbiology laboratory start-up and ongoing operations for GMP-ready facilities. You will guide transfer of analytical methods, establish QMS processes, and ensure data integrity across all activities.

This role reports to the Senior Manager, Quality Control and requires onsite work. Ideal candidates hold a Bachelor's in Microbiology/Biotechnology, with 5+ years in QC Microbiology, and

Qualifications

• Bachelor’s degree in Microbiology or biotechnology is required.
• Master’s degree in Microbiology or related life science is preferred.
• Minimum 5 years of QC Microbiology experience in GxP environments.
• Experience with regulatory inspections and quality systems is required.

Responsibilities

• Provide technical and compliance leadership to QC Microbiology processes.
• Qualify, transfer, and perform microbiological methods in a GxP setting.
• Lead sampling, culturing, microscopy, and aseptic technique work.
• Train staff on microbiology methods and GMP procedures.
• Coordinate sampling and testing tasks; review QC results.
• Prepare laboratory reports and communicate findings to stakeholders.
• Collaborate with QA/Quality Systems for inspection readiness.
• Investigate non-conformances and manage CAPAs.

Skills

MS Office Suite

Lean Labs

Education

Bachelor's degree in Microbiology/Biotechnology

Master's degree in Microbiology or life sciences (preferred)

Tools

LIMS/ELN/LES

VEEVA QMS

Job description

Kyowa Kirin, Inc. in Sanford, NC is seeking a Senior/Sr Specialist Quality Control Microbiology to lead the QC Microbiology laboratory start-up and ongoing operations for GMP-ready facilities. You will guide transfer of analytical methods, establish QMS processes, and ensure data integrity across all activities.

This role reports to the Senior Manager, Quality Control and requires onsite work. Ideal candidates hold a Bachelor's in Microbiology/Biotechnology, with 5+ years in QC Microbiology, and