Technician I, 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: 

As a Technician I, GMP Manufacturing - Downstream you will play a vital role in the production and purification of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. This position offers an exciting opportunity to contribute to the development and manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

What You'll Bring:

• Perform routine 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.
• Prepare and operate equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring they are properly calibrated and maintained.
• Execute purification processes for AAV-based gene therapy products, adhering to cGMP guidelines and maintaining a clean and organized work area.
• Monitor critical process parameters during manufacturing operations and report any deviations or abnormalities to the supervisor in a timely manner.
• Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
• Assist in the execution of process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
• 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.
• Additional responsibilities not listed may be assigned as needed by management.

What You'll Bring:

• Associate’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with +2 years of related 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.
• Ability 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.

Physical Requirements:

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or