Technician I, GMP Manufacturing - Fill/Finish

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 a detail-oriented and highly motivated individual to join our Fill/Finish Manufacturing team. As a Technician I, GMP Manufacturing – Fill/Finish you will play a crucial role in the aseptic filling and finishing operations of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position presents an exciting opportunity to contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

What You’ll Do  

• Execute aseptic filling and finishing operations according to Standard Operating Procedures (SOPs) and batch records, ensuring compliance with cGMP guidelines and quality standards.
• Prepare and operate filling equipment, such as semi-automated and automated fillers, stoppering machines, cappers, and labeling machines, following established procedures, and ensuring proper setup, calibration, and maintenance.
• Perform line clearances, sanitization, and sterilization of equipment and manufacturing areas to maintain aseptic conditions.
• Assemble, disassemble, and clean equipment components, ensuring proper sterilization procedures are followed.
• Monitor critical process parameters, including fill volumes, stopper/cap placement, torque, and label alignment, and promptly report deviations or abnormalities.
• Conduct in-process testing and quality control checks, such as visual inspections, particle count, and container closure integrity tests, to ensure product quality and compliance.
• Accurately document manufacturing activities and data in compliance with cGMP regulations and company policies.
• Collaborate with cross-functional teams, to investigate and resolve deviations, non-conformances, and quality incidents.
• Support process improvement initiatives to enhance efficiency, productivity, and compliance.
• Follow safety protocols and environmental health guidelines to maintain a safe workspace.
• Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.

What You’ll Bring  

• Associate’s or Bachelor’s degree in a scientific, technical, or related field preferred; or equivalent professional experience.
• Previous experience working in a regulated manufacturing or laboratory environment.
• 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.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Strong problem-solving skills and ability to identify and escalate issues as needed.
• Willingness to work flexible hours, including evenings, weekends, and holidays to support manufacturing production schedules.
• Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

 Preferred Skills   

• Prior experience working in a cGMP manufacturing environment.
• Experience