Sr. Technician, 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 Senior Technician, 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 completion and compliance with cGMP guidelines and quality standards.
• Demonstrate proficiency and competency by ensuring all tasks are performed in a manner consistent with cGMP SOPs and safety 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 activities for the filling equipment and manufacturing areas to maintain aseptic conditions.
• Assemble and disassemble equipment, such as filling heads, tubing, filters, and fittings, for cleaning and sterilization purposes, adhering to proper cleaning procedures.
• Monitor critical process parameters during filling and finishing operations, including fill volumes, stopper/cap placement, torque, and label alignment, and report any deviations or abnormalities to management
• 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 with specifications.
• Document all manufacturing activities, data, and results accurately and in compliance with cGMP regulations and company policies.
• Drive ownership of deviations/discrepancies in collaboration with cross-functional teams, including Quality Assurance (QA), Quality Control (QC), Quality Validation (QE), and Facilities & Engineering (F&E) to investigate and resolve deviations, non-conformances, and quality incidents related to filling and finishing processes.
• Manage and assess Change Controls and CAPAs, contributing to impact assessments to support process improvements that enhance efficiency, productivity, and regulatory compliance within the Fill/Finish manufacturing area.
• Demonstrate good aseptic techniques and serve as a trainer and mentor to junior technicians.
• Qualify for ISO-6 cleanroom gowning protocol and maintain annual certification to ensure compliance with GMP standards.
• Follow safety procedures and adhere to environmental health and safety guidelines to maintain a safe working environment.
• Participate in training programs and stay updated with current industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.

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).
• 4+ years of experience in aseptic techniques and troubleshooting fill/finish equipment.
• Able to perform multi-hour processing events wi