Sr. Technician, GMP Manufacturing - Upstream

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 skilled individual to join our Upstream Manufacturing team. As a Senior Technician, GMP Manufacturing – Upstream you will play a pivotal role in the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. Your expertise in upstream bioprocessing and strong leadership abilities will contribute to the success of our manufacturing operations and the delivery of cutting-edge therapies that have the potential to transform the lives of patients.

What You’ll Do  

• Lead and execute complex upstream manufacturing operations, including cell culture expansion, transfection, and harvest steps, according to Standard Operating Procedures (SOPs) and batch records.
• Independently prepare, operate, and troubleshoot bioreactors, centrifuges, filtration systems, and other equipment required for upstream processing, ensuring optimal performance and compliance.
• Oversee the preparation of complex media and buffers, ensuring cGMP guidelines and maintaining aseptic conditions throughout the process.
• Monitor critical process parameters during manufacturing operations, analyze data, and proactively identify and address deviations or abnormalities, ensuring timely reporting and resolution.
• Perform advanced sampling and in-process testing, and data analysis, utilizing analytical techniques such as cell counts, viability determination, and metabolite analysis, and other relevant assays to assess culture conditions and product quality.
• Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
• Collaborate 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 GMP Technicians I and II, 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 work environment.
• Stay updated with the latest advancements in gene therapy upstream manufacturing processes, regulatory requirements, and industry trends, and actively contribute to the continuous improvement of manufacturing processes.
• Additional responsibilities not listed may be assigned as needed by management.

What You’ll Bring  

• Associate’s or Bachelor’s Degree in Biology, Biochemistry, Biomedical Engineering or related life science field, or equivalent professional experience.
• 5+ years of experience working in a GMP manufacturing environment, with a focus on upstream bioprocessing or biologics manufacturing.
• Strong expertise and hands-on experience with advanced cell culture techniques, bioreactors (e.g., single-use bioreactors), centrifuges, filtration systems, and other upstream processing equipment.
• Proficiency in media and buffer preparation, aseptic techniques, and analytical methods commonly