Sr. Technician, GMP Manufacturing - Downstream

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.    

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.

What You’ll Do  

• 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.

What You’ll Bring  

• 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..
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Excellent attention to detail and ability to accura