Forge Biologics is a gene therapy development engine, focused on enabling access to life-changing gene therapies and helping bring them from an idea into reality. Backed by Drive Capital.
About the role
Senior Analyst, Quality Control (EM &Micro) will serve as Subject Matter Expert (SME) for EM testing and Microbiology Lab testing and takes ownership of the different testing, collaborating of quality initiatives and in providing technical guidance to the junior staff. This role provides opportunities to utilize experience and implement new technologies in QC Microbiology.
What they're looking for
- Bachelor’s degree in microbiology, Biology or related scientific field required
- Minimum of 4 years of experience in a GMP-regulated QC or EM environment including Microbiology Laboratory
- Demonstrate proficiency and understanding of Environmental Monitoring, Clean room sampling with air samplers (viable and non-viable), surface sampling
- Experience in understanding/ implementing RMMs and other new methodologies ( eg, Sterility testing)
- Demonstrated experience in drafting EMPQ protocols, risk assessments, and final EMPQ reports, etc
- Demonstrated experience in performing Deviations and Lab investigations, Change controls, CAPAs and new document/SOP creation using Veeva Vault/Trackwise, and other software (JMP, LIMS, NetSuites etc.)
More about this role
At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.
Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.
What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve...
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