Our leading pharmaceutical client in Ohio is looking for a skilled Senior QC Microbiologist to drive microbiology-focused projects. This role will involve method development, validation, and compliance, and have a strong focus on technical writing.

If you are a seasoned pharmaceutical microbiologist looking to expand your experience outside the lab, apply to this ad or reach out to Jessica Goodman to learn more!

Job Responsibilities:

• Lead microbiology-related projects, guiding solutions for technical challenges.
• Support the development, verification, and validation of microbiological methods, including sterility, endotoxin, and bioburden testing.
• Contribute to regulatory submissions (INDs, BLAs) and technical reports, with a significant focus on technical writing
• Assist in method transfers, equipment installation, and troubleshooting microbiological instrumentation (plate readers, endotoxin testing equipment, etc.).
• Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits.
• Collaborate cross-functionally with teams in Manufacturing, Process Development, Validation, and Quality.

Requirements:

• BS degree
• 5+ years of microbiology experience in the pharmaceutical industry
• Strong experience in microbiological method development and validation
• Experience with equipment qualification (PQ/OQ)
• Excellent technical writing skills