Technician II, 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 Team 

The GMP Manufacturing department is responsible for the manufacturing of AAV Gene Therapy products in accordance with the highest standards of Good Manufacturing Practices (GMPs). This department ensures that the products produced are of the highest quality and meet all applicable regulatory requirements. This team works together to ensure the production of safe and effective Gene Therapy products.

About The Role

We’re seeking an experienced and detail-oriented professional to join our Upstream Manufacturing team as a Technician II, GMP Manufacturing. In this role, you’ll be hands-on in the production and cultivation of AAV-based gene therapy products, ensuring compliance with cGMP regulations every step of the way. This is an exciting opportunity to utilize your expertise in upstream bioprocessing and contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

What You’ll Do

• Execute and oversee upstream manufacturing operations, including cell culture expansion, transfection, and harvest steps, according to Standard Operating Procedures (SOPs) and batch records.
• Prepare and operate bioreactors, centrifuges; filtration systems, and other equipment required for upstream processing, ensuring proper calibration, maintenance, and troubleshooting when needed.
• Perform complex media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines.
• Monitor process parameters during manufacturing operations, analyze data, and proactively identify and report deviations.
• Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, and other analytical techniques, to ensure product quality.
• Accurately document all manufacturing activities, data, and results in accordance with cGMP regulations and company policies.
• Partner with Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents.
• Support process improvement initiatives, including evaluating new technologies, equipment, and methods to enhance manufacturing efficiency, productivity, and compliance.
• Mentor and train junior technicians, providing guidance on procedures and best practices.
• Follow safety protocols and maintain a clean, compliant work environment.
• Stay informed on industry trends, regulatory requirements and share knowledge with team.

What You’ll Bring 

• Bachelor’s Degree in Biology, Biochemistry, Biomedical Engineering or related field (or equivalent experience).
• Experience working in a GxP or regulated environment.
• Hands-on experience with cell culture techniques, bioreactors, centrifuges, filtration systems, and other upstream processing equipment.
• Skilled in aseptic techniques, media and buffer preparation, and upstream analytical methods.
• Detail-oriented with strong documentation and data recording skills.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Strong teamwork and communication skills to collaborate effectively across departments.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Experience and ability to mentor and train junior team members.
• Ability to work f