Senior GMP Technician, Downstream

About the role

We are seeking an experienced and highly skilled individual to join our Downstream Manufacturing team. As a Senior Technician, GMP Manufacturing - Downstream you will play a pivotal role in the purification and processing of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. Your expertise in downstream bioprocessing and strong leadership abilities will contribute to the success of our manufacturing operations and the delivery of cutting-edge gene therapies that have the potential to transform the lives of patients.

Responsibilities

• Lead and execute downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
• Independently prepare, operate, and troubleshoot advanced downstream equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring optimal performance and compliance.
• Monitor critical process parameters during manufacturing operation, analyze data, and proactively identify and address deviations or abnormalities, ensuring timely reporting and resolution.
• Perform in-process testing and quality control checks, such as pH, conductivity, pressure measurements, and other analytical techniques to ensure product quality and compliance with specifications.
• Lead and document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
• Collaborate closely with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents, ensuring compliance with regulations and meeting production timelines.
• Drive process improvements by evaluating new technologies, equipment, and methods, and leading the implementation of strategies to enhance manufacturing efficiency, productivity, and compliance.
• Mentor and train junior team members, providing guidance on process execution, troubleshooting, and adherence to cGMP guidelines.
• Ensure the highest standards of safety procedures and environmental health and safety guidelines are followed, maintaining a safe working environment.
• Stay updated with the latest advancements in gene therapy downstream manufacturing processes, regulatory requirements, and industry trends, and actively contribute to the continuous improvement of manufacturing practices.

Requirements

• Bachelor's Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
• Prior experience working in a GxP or regulated environment.
• Downstream processing or biologics manufacturing experience.
• Extensive expertise and hands-on experience with downstream processing techniques and equipment, such as chromatography systems, filtration systems, centrifuges, and TFF systems.
• Proficiency in conducting in-process testing and quality control checks to ensure product quality and compliance..
• Excellent attention to detail and ability to accurately document and record experimental data and manufacturing activities.
• Strong organizational skills and t

Benefits

Additional Information

Forge Your Future with Us: 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 together. At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us. If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.

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