Lead GMP Technician, Downstream

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.

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.

• Lead downstream operations for the purification of viral‑based vectors related to gene therapy GMP in a cleanroom environment.
• Planning and managing fordownstreamactivities, process optimization, and technology transfer to cGMP forviralvectors.
• Demonstrateproficiencyonthe specific equipment associated withdownstreamprocesses, such ascolumn 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 oversighttoauthor reports andanalyzeresults forclient facingsummaries.
• Collaborate with Quality Systems, including QA and QC, to work toward efforts that satisfy GMP regulations andguidances.
• Train and mentorjuniortechnicians; perform periodic review of direct reports.
• Reportingunexpected issuesbyinitiatingdeviations, participating in investigation,determiningroot-cause,and implementing CAPA.
• Partnerwiththe Technical Writing team to draft,revise,and review GMP documentation.

• 4+years of relevant experience in downstream GMP manufacturing, withadditionalpreference 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 tooperateand 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…