GMP Technician I, Downstream

Forge Biologics; Columbus (OH); Sur place; USD 45 000 - 65 000; Plein temps

Avantages offerts par ce poste

Health insurance

PTO

Parental leave

Annual bonus

401(k) match

Employee discounts

Onsite gym

EAP

Disability coverage

Free snacks

Résumé du poste

Forge Biologics in Columbus, OH is seeking a Technician I, GMP Manufacturing - Downstream, to contribute to the production and purification of AAV-based gene therapies under cGMP guidance.

You will operate chromatography and filtration systems, monitor processes, and collaborate across teams to ensure quality, safety, and on-time delivery. The role requires a Bachelor's in life sciences and the ability to work in shifts.

Qualifications

• Bachelor’s degree in life sciences or related field required.
• Strong technical problem-solving abilities.
• Ability to work under strict timelines in GMP settings.
• Excellent communication and teamwork skills.
• Commitment to SOPs and safety.

Responsabilités

• Perform downstream manufacturing operations including chromatography, filtration, ultrafiltration/diafiltration per SOPs.
• Prepare and operate chromatography, filtration, centrifugation, and TFF systems.
• Execute purification processes for AAV products per cGMP guidelines.
• Monitor critical process parameters and report deviations promptly.
• Perform in-process testing (pH, conductivity, pressure) to ensure quality.
• Assist in process validation and technology transfer with cross-functional teams.
• Follow safety procedures and EH&S guidelines in a cleanroom.
• Participate in training and stay updated on industry trends.

Connaissances

Technical aptitude

Problem solving

Organizational skills

Communication skills

Regulatory compliance

Team player

Formation

Bachelor’s degree in Biology/biomedical field

Description du poste

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 ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, 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:

As a Technician I, GMP Manufacturing - Downstream you will play a vital role in the production and purification 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:

• Perform routine downstream manufacturing operations, including but not limited to chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation steps, according to Standard Operating Procedures (SOPs) and batch records.
• Prepare and operate equipment, such as chromatography systems, filtration systems, centrifuges, and tangential flow filtration (TFF) systems, ensuring they are properly calibrated and maintained.
• Execute purification processes for AAV-based gene therapy products, 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.
• Perform in-process testing and quality control checks, such as pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
• Assist in the execution of process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
• 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:

• Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• 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.
• 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 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.
• Downstream processing or biologics manufacturing experience.
• Familiarity with purification techniques and equipment commonly used in downstream bioprocessing, such as chromatography systems, filtration systems, and TFF systems.
• Basic understanding of viral vector-based gene therapy processes, principles, 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 Environment and Physical Demands

This position is performed in a temperature-controlled laboratory or office environment and requires regular standing, hand manipulation, and use of laboratory equipment. The role may involve lifting or moving materials up to 25 pounds and occasional reaching or handling at various heights. Appropriate personal protective equipment (PPE) must be worn when working with chemicals, biological materials, or in controlled environments.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

• Health, dental and vision insurance start your first day – with 90% of premiums covered for youandyour family.

Time to recharge

• A competitive paid time off plan – because rest fuels innovation.
• 12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

• Annual bonus opportunities for all full-time team members.
• 401(k) with company match to help you plan for the future.
• Special employee discounts, including childcare and dependent care savings.
• Onsite fitness facility at The Hearth.
• Mental health counseling and financial planning services through our Employee Assistance Program.
• Employer-paid short and long-term disability coverage to protect your peace of mind.

Fuel for your workday

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.