GMP Technician II, Upstream

About the role

Technician II, GMP Manufacturing - Upstream will be hands-on in the production and cultivation of AAV-based gene therapy products, ensuring compliance with cGMP regulations every step of the way. This is an exciting opportunity to utilize your expertise in upstream bioprocessing and contribute to the manufacturing of cutting-edge therapies that have the potential to transform the lives of patients.

Responsibilities

• Execute and oversee 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, maintenance, and troubleshooting when needed.
• Perform complex media and buffer preparation, as well as the aseptic transfer of materials, adhering to cGMP guidelines.
• Monitor process parameters during manufacturing operations, analyze data, and proactively identify and report deviations.
• Conduct sampling and in-process testing, such as cell counts, viability, and metabolite analysis, and other analytical techniques, to ensure product quality.
• Accurately document all manufacturing activities, data, and results in accordance with cGMP regulations and company policies.
• Partner with Quality Assurance (QA) and Quality Control (QC), to investigate and resolve deviations, non-conformances, and quality incidents.
• Support process improvement initiatives, including evaluating new technologies, equipment, and methods to enhance manufacturing efficiency, productivity, and compliance.
• Mentor and train junior technicians, providing guidance on procedures and best practices.
• Follow safety protocols and maintain a clean, compliant work environment.

Requirements

• Bachelor's Degree in Biology, Biochemistry, Biomedical Engineering or related field (or equivalent experience).
• Experience working in a GxP or regulated environment.
• Hands-on experience with cell culture techniques, bioreactors, centrifuges, filtration systems, and other upstream processing equipment.
• Skilled in aseptic techniques, media and buffer preparation, and upstream analytical methods.
• Detail-oriented with strong documentation and data recording skills.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.
• Experience and ability to mentor and train junior team members.
• 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.
• Preferred Skills:
• Prior cGMP manufacturing experience.
• Upstream bioprocessing or biologics manufacturing experience.
• Familiarity with viral vector-based gene therapy processes and quality requirements.
• This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned.
• Work En

Benefits

Additional Information

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.

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