GMP Technician , Upstream

Position: GMP Technician I, Upstream
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:

We are seeking a detail-oriented and highly motivated individual to join our GMP Manufacturing, Upstream team. As a Technician I, GMP Manufacturing - Upstream you will play a critical 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 escalate 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…