GMP Technician I - Downstream

1w1 week ago

Forge Biologics

Columbus, US · Full-time · $48,000 – $62,000

About this role

At Forge Biologics, we turn bold ideas into life-changing realities by enabling access to gene therapies. As a Technician I, GMP Manufacturing - Downstream, you play a vital role in producing and purifying AAV-based gene therapy products under cGMP regulations. This position contributes to therapies that transform lives of patients with genetic diseases.

Team members work out of The Hearth, a state-of-the-art 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you scale AAV manufacturing, collaborate on cutting-edge therapies, and support complex technical projects. You bring hope to patients through hands-on involvement in innovation.

Forge stands out with its H.O.P.E. culture: hardworking with determination and grit, open where ideas flow freely, purpose-driven tying every task to changing lives, and engaged by challenges and milestones. Every voice is valued in this collaborative environment. The focus remains on improving lives through partnerships with scientists and innovators.

Your growth matters at Forge, with commitment to expanding skills via mentorship, hands-on learning, and advancement opportunities. Team members develop careers while investing in people. Join to use your talent delivering hope worldwide and be part of something bigger.

Requirements

Associate’s or Bachelor’s degree in a scientific field, or relevant industry certifications; or high school diploma with equivalent professional experience
Familiarity with cGMP regulations and guidelines
Hands-on experience with downstream processing equipment like chromatography and TFF systems
Ability to follow Standard Operating Procedures (SOPs) and batch records precisely
Proficiency in in-process testing including pH, conductivity, and pressure measurements
Attention to detail for monitoring process parameters and reporting deviations
Basic mechanical aptitude for equipment preparation and maintenance
Understanding of safety protocols in biomanufacturing environments

Responsibilities

Perform routine downstream manufacturing operations including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps according to SOPs and batch records
Prepare and operate equipment such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring proper calibration and maintenance
Execute purification processes for AAV-based gene therapy products adhering to cGMP guidelines and maintaining a clean work area
Monitor critical process parameters during manufacturing operations and report deviations or abnormalities to supervisor
Perform in-process testing and quality control checks such as pH, conductivity, and pressure measurements to ensure product quality
Assist in process validation and technology transfer activities, collaborating with cross-functional teams
Follow safety procedures and environmental health and safety guidelines
Participate in training programs and stay updated on gene therapy manufacturing advancements