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Forge Biologics is seeking a GMP Technician I for Upstream Manufacturing to support the production and cultivation of AAV-based gene therapy products in compliance with current Good Manufacturing Practices (cGMP) regulations. You will work at The Hearth, a state-of-the-art 200,000-square-foot cGMP facility in Columbus, Ohio, contributing to cutting-edge therapies designed to transform the lives of patients with genetic diseases.
Key Responsibilities:
- Execute upstream manufacturing operations including cell culture expansion, transfection, and harvest steps according to Standard Operating Procedures (SOPs) and batch records
- Prepare and operate bioreactors, centrifuges, filtration systems, and other equipment required for upstream processing, ensuring proper calibration and maintenance
- Perform media and buffer preparation and aseptic transfer of materials while adhering to cGMP guidelines
- Monitor critical process parameters during manufacturing operations and report deviations or abnormalities to supervisors
- Conduct sampling and in-process testing such as cell counts, viability, and metabolite analysis to ensure optimal culture conditions and product quality
- Document all manufacturing activities, data, and results accurately in compliance with cGMP regulations and company policies
- Collaborate with Quality Assurance (QA) and Quality Control (QC) teams to investigate and resolve deviations, non-conformances, and quality incidents
- Participate in process improvement initiatives and support implementation of new technologies and methods
- Follow safety procedures and environmental health and safety guidelines
- Participate in training programs and stay updated with industry trends and regulatory requirements
The role requires flexibility to work shifts including weekends and holidays as required by manufacturing schedules. You will work in a temperature-controlled laboratory environment, standing for extended periods, wearing appropriate gowning and PPE in a cleanroom setting. Physical demands include regular hand manipulation, use of laboratory equipment, and occasional lifting or moving of materials up to 25 pounds.
Qualifications:
- 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 ability to multitask in a fast-paced environment while adhering to strict timelines
- Good interpersonal and communication skills, both written and verbal
- Commitment to following SOPs, safety protocols, and regulatory guidelines
- Strong problem-solving skills and ability to identify and escalate issues
- Ability to adapt to changing priorities and work independently as well as part of a team
- Flexibility to work shifts, including weekends and holidays
- Ability to stand for extended periods and work in a cleanroom environment with appropriate gowning and PPE
Preferred Skills:
- Prior experience in a cGMP manufacturing environment
- Upstream bioprocessing or biologics manufacturing experience
- Familiarity with cell culture techniques, bioreactors, centrifuges, and filtration systems
- Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements
