GMP Technician I, Upstream

forgebiologics; Columbus (OH); On-site; USD 55,000 - 85,000; Full time

Job summary

Forge Biologics is seeking a Technician I, GMP Manufacturing - Upstream in Columbus, Ohio. You will play a crucial role in producing AAV-based gene therapies, handling cell culture, transfection, and harvest under cGMP guidelines.

The role involves operating bioreactors and downstream equipment, maintaining documentation, and collaborating with QA/QC to ensure product quality and process improvements. Weekend shift availability may be required.

Qualifications

• Associate’s or Bachelor's degree in a scientific field, or a related industry certification; or a high school diploma with 2+ years of related experience.
• Experience in a regulated manufacturing or laboratory environment.
• Ability to multitask in a fast-paced setting while meeting strict timelines.
• Excellent written and verbal communication to collaborate with teams and stakeholders.
• Adherence to SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.

Responsibilities

• Execute upstream manufacturing operations, including cell culture expansion, transfection, and harvest according to SOPs and batch records.
• Operate bioreactors, centrifuges, filtration systems, and related equipment with proper calibration and maintenance.
• Prepare media and buffers; perform aseptic transfers while maintaining a cleanroom environment.
• Monitor process parameters and report deviations to supervision promptly.
• Perform sampling and in-process testing for cell counts, viability, and metabolite analysis.
• Document manufacturing activities accurately and in compliance with cGMP and company policies.
• Collaborate with QA and QC to investigate deviations and quality incidents as needed.
• Participate in process improvements and adopt new technologies or methods to enhance efficiency.
• Adhere to safety guidelines and participate in ongoing training on industry trends.

Skills

Cell culture

SOP compliance

cGMP knowledge

Troubleshooting

Documentation

Education

Bachelor's or Associate degree

Tools

Bioreactors

Centrifuges

Filtration systems

Job description

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities - all united by one goal: improving lives. If you're driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won't just watch innovation happen - you'll be part of it. Whether you're scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you'll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We're committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we're proud to see team members grow with us.

If you're ready to use your talent to help deliver hope to patients around the world, join us - and be part of something bigger than yourself.

About The Role:

The Technician I, GMP Manufacturing - Upstream will play a c ritical role in the production and cultivation 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.

Responsibilities:

• Execute upstream manufacturing operations, including but not limited to 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 they are properly calibrated and maintained.
• Perform media and buffer preparation, as well as the aseptic transfer of materials, 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.
• 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 and in compliance with cGMP regulations and company policies.
• Collaborate with cross-functional teams, including Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents related to upstream manufacturing processes.
• Participate in process improvement initiatives and support the implementation of new technologies, equipment, and methods to enhance manufacturing efficiency and productivity.
• 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.

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 the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Strong problem-solving skills and ability to identify and elevate issues as needed.
• Ability to adapt to changing priorities and work independently as well as part of a team.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules.
• Ability to stand for extended periods, and work in a cleanroom environment while wearing appropriate gowning and PPE.

Preferred Skills:

• Prior experience working in a cGMP manufacturing environment.
• Upstream bioprocessing or biologics manufacturing experience.
• Familiarity with cell culture techniqu