GMP Technician I - Upstream

1w1 week ago

Forge Biologics

Columbus, US · Full-time · $55,000 – $75,000

About this role

At Forge Biologics, we turn bold ideas into life-changing realities by enabling access to gene therapies. As a GMP Technician I - Upstream, you will play a critical role in producing AAV-based products in compliance with cGMP regulations. Join our mission to partner with innovators and improve patient lives.

You will execute upstream operations like cell culture expansion, transfection, and harvest in our 200,000-square-foot cGMP facility. Prepare bioreactors, perform media prep, and monitor process parameters to ensure product quality. Conduct sampling for cell counts and viability while maintaining aseptic conditions.

Our team embodies H.O.P.E.: hardworking with grit, open to ideas, purpose-driven to change lives, and engaged in challenges. Work out of The Hearth in Columbus, Ohio, scaling AAV manufacturing and supporting technical projects. Collaborate with QA and QC on deviations and improvements.

Grow your skills through mentorship, hands-on learning, and advancement opportunities. Contribute to cutting-edge therapies bringing hope to genetic disease patients. Be part of something bigger at Forge Biologics.

Requirements

Detail-oriented mindset for precise execution of SOPs and batch records
Knowledge of cGMP regulations and aseptic processing techniques
Familiarity with cell culture expansion, transfection, and harvest procedures
Ability to operate bioreactors, centrifuges, and filtration systems
Proficiency in monitoring process parameters and in-process sampling
Skill in accurate documentation of manufacturing data
Experience with media/buffer preparation and cleanroom maintenance
Understanding of safety procedures in biomanufacturing environments

Responsibilities

Execute upstream manufacturing operations, including cell culture expansion, transfection, and harvest steps, according to SOPs and batch records.
Prepare and operate bioreactors, centrifuges, filtration systems, and other equipment for upstream processing.
Perform media and buffer preparation, as well as aseptic transfer of materials, adhering to cGMP guidelines.
Monitor critical process parameters during manufacturing and report deviations to supervisor.
Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis.
Document all manufacturing activities, data, and results accurately in compliance with cGMP.
Collaborate with QA and QC to investigate deviations and resolve quality incidents.
Participate in process improvement initiatives and support new technologies for efficiency.