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Forge Biologics is seeking a Senior Analyst for Quality Control specializing in Electron Microscopy (EM) and Microbiology testing. Based at The Hearth, a 200,000-square-foot cGMP manufacturing facility in Columbus, Ohio, this role focuses on gene therapy manufacturing and AAV production.
As Subject Matter Expert (SME) for EM and Microbiology Lab testing, you will own testing execution, collaborate on quality initiatives, and provide technical guidance to junior staff. Key responsibilities include:
- Serve as SME for EM and Microbiology testing, troubleshooting, method enhancement, and sample management
- Establish testing timelines and execute monitoring for Growth Promotion, Bioburden, Microbial ID, Bubble Point, Endotoxin, Sterility, pH, Osmolality, and Biological Indicators
- Write and implement SOPs, work instructions, and protocols in compliance with cGMP standards
- Mentor junior analysts and support technical development
- Collaborate on quality initiatives and process improvements
- Utilize and implement new testing technologies in QC Microbiology
This is a 2nd shift position offering opportunities to leverage existing expertise while driving innovation in quality control processes. The role combines hands-on technical work with mentorship and strategic quality improvement initiatives in a mission-driven biotech environment focused on bringing life-changing gene therapies to patients with genetic diseases.
