Kyowa Kirin – Sr Specialist, Quality Control-Microbiology (Microbiology/Biotechnology Degree) – Apply Now
Are you an experienced and skilled Quality Control Microbiologist with a Bachelor’s or preferably a Master’s degree in Microbiology, Biotechnology, or a related life science, and at least 5 years of GxP biopharmaceutical manufacturing experience? Kyowa Kirin, a fast-growing global specialty pharmaceutical company, is seeking a Sr Specialist, Quality Control-Microbiology to join our team in Sanford, NC. If you have a passion for providing technical and compliance leadership in a QC Microbiology laboratory setting and are eager to contribute to the start-up and operations of a new monoclonal antibody drug substance manufacturing facility, apply now!
About Kyowa Kirin
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.
Job Title: Sr Specialist, Quality Control-Microbiology
Location: Sanford, NC
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.
Reporting to: Senior Manager, Quality Control
Technical Skills, Knowledge, and Experience
- Provide technical and compliance leadership to business processes within QC Microbiology scope of responsibilities.
- 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.
- Expertise on Sampling, Culturing, Microscopy, and Aseptic Techniques.
Education
- Bachelor’s degree in Microbiology, Biotechnology, or life sciences (minimum)
- Master’s degree in Microbiology or related life science (preferred)
Experience
- At least 5 years of experience in Quality Control Microbiology laboratory providing technical and compliance leadership within GxP Biopharmaceutical Manufacturing operations.
Keywords: Sr Specialist, Quality Control-Microbiology, Kyowa Kirin, Sanford, NC, Quality Control, Microbiology, GxP, Biopharmaceutical Manufacturing, Technical Leadership
