GMP Technician I, Downstream

The role

You will perform downstream manufacturing operations for AAV-based gene therapy products. This includes chromatography, filtration, and viral vector formulation in compliance with cGMP regulations.

What you will do

• Perform routine downstream manufacturing operations including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation.
• Prepare and operate equipment such as chromatography systems, filtration systems, centrifuges, and TFF systems.
• Execute purification processes for AAV-based gene therapy products.
• Monitor critical process parameters and report deviations or abnormalities.
• Perform in-process testing and quality control checks like pH, conductivity, and pressure measurements.
• Assist in process validation and technology transfer activities.
• Follow safety procedures and environmental health and safety guidelines.
• Participate in training programs.

Required qualifications

• Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
• Strong technical aptitude with experience applying scientific reasoning to solve complex problems.
• Excellent organizational skills and ability to multitask in a fast-paced environment.
• Good interpersonal and communication skills.
• Commitment to following SOPs, safety protocols, and regulatory guidelines.
• Ability to adapt to changing priorities and work independently or as part of a team.
• Flexibility to work in shifts, including weekends and holidays.
• Ability to stand for extended periods.
• Ability to work in a cleanroom environment while wearing appropriate gowning and PPE.
• Regular standing, hand manipulation, and use of laboratory equipment.
• Ability to lift or move materials up to 25 pounds.
• Occasional reaching or handling at various heights.

Nice to have

• Prior experience working in a cGMP manufacturing environment.
• Downstream processing or biologics manufacturing experience.
• Familiarity with purification techniques and equipment such as chromatography systems, filtration systems, and TFF systems.
• Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

Benefits

• Health, dental and vision insurance start your first day with 90% of premiums covered for you and your family.
• Competitive paid time off plan.
• 12 weeks of fully paid parental leave.
• Annual bonus opportunities for all full-time team members.
• 401(k) with company match.
• Special employee discounts, including childcare and dependent care savings.
• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through Employee Assistance Program.
• Employer-paid short and long-term disability coverage.
• Fully stocked kitchen with free snacks and beverages.
• Ongoing professional development resources, training, and mentorship programs.

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.