Lead GMP Technician, Downstream

About this role

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 currently seeking a Lead , GMP Manufacturing   - Downstream to join the Forge Biologics team. This is an exciting opportunity to provide active leadership and execution of the Standard Operating Procedures and Master Production Records for downstream manufacturing processes within Forge’s state-of-the-art cleanroom facility. The role will manage a team of technicians at various levels who implement and perform downstream operations , interacting with clients to complete projects for viral vector purification methods according to client specifications. The ideal candidate will be skilled in technical problem-solving and laboratory techniques to support our growth in the Gene Therapy sector.

Responsibilities:

• Lead downstream operations for the purification of viral-based vectors related to gene therapy GMP in a cleanroom environment.

• Planning and managing for downstream activities, process optimization, and technology transfer to cGMP for viral vectors.

• Demonstrate proficiency on the specific equipment associated with downstream processes, such as column packing/testing, TFF, and Affinity/Anion Exchange Chromatography.

• Complete and review documentation concurrently with completion of manufacturing processes.

• Collaborate with MS&T to support internal process transfer activities from Process Development to GMP.

• Compile data with minimal oversight to author reports and analyze results for client facing summaries.

• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations and guidances.

• Train and mentor junior technicians; perform periodic review of direct reports.

• Reporting unexpected issues by initiating deviations, participating in investigation, determining root-cause, and implementing CAPA.

• Partner with the Technical Writing team to draft, revise, and review GMP documentation.

Qualifications:

• 4+ years of relevant experience in downstream GMP manufacturing, with additional preference for relevant BS or MS degrees

• Demonstrated experience in downstream techniques, including column packing/testing, tangential flow filtration (TFF), and affinity/anion exchange chromatography

• Proficiency in purification processes, such as chromatography, filtration, and centrifugation, with a proven ability to operate and troubleshoot equipment in downstream GMP manufacturing environments

• Working knowledge of cGMP requirements and biological drug development

• Must be self-motivating, organized, and proactive

• Ability to work the hours necessary to support production and/or product transfer activities

• Ability to work in loud noise environments and in Personal Protective Equipment (PPE)

Preferred Skills:

• Working knowledge of aseptic techniques and automated systems

• Experience with gene therapy manufacturing and proficiency in using single-use technologies within a GMP downstream processing environment

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 works in both a laboratory environment and a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area. Must be able to lift heavy objects up to 50 lbs.

This role requires scheduling flexibility to support GMP manufacturing operations, including the ability to flex hours, work weekends or holidays, and adapt to changing shift assignments based on production demands. Shift schedules may change with limited notice, and work assignments will be determined according to business needs to ensure uninterrupted manufacturing support. The position also requires the ability to complete int

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