Associate Scientist II, MS&T Columbus, Ohio
Listed on 2026-06-05
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Engineering
Process Engineer, Manufacturing Engineer
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:As an Associate Scientist II, you will play a key role in developing, optimizing, and supporting gene therapy manufacturing processes within the Manufacturing Science and Technology (MS&T) department. This multidisciplinary position partners closely with process development, manufacturing, quality, validation, facilities and engineering, and regulatory teams to ensure upstream, downstream, fill‑finish, buffer preparation, and support‑function processes are scalable, robust, and aligned with regulatory expectations.
In this role, you will execute moderately complex, recurring assignments using established procedures, applying sound judgment to resolve straightforward issues and escalating exceptions when needed. You will help identify minor process gaps, contribute to continuous improvement efforts, and strengthen overall operational reliability. Through this work, you will support day‑to‑day operational excellence, enhance cross‑functional readiness, and contribute meaningfully to the organization’s broader success.
- Execute technology transfer activities from Process Development or clients into GMP Manufacturing, including defining critical quality attributes, key process parameters, and conditions essential for compliant manufacturing under cGMPs.
- Serve as a technical contributor during technology transfer by reviewing client and Process Development processes and generating required transfer documentation.
- Support the development, review, and maintenance of key documentation such as manufacturing batch records, production plans, bills of materials and SOPs.
- Perform process monitoring by collecting, analyzing, and summarizing manufacturing data; prepare and present campaign summaries and related reports.
- Support GMP execution of new processes and act as a Subject Matter Expert (SME) for change controls, deviation investigations, and CAPAs.
- Track progress of routine manufacturing and technology transfer activities, provide timely updates, and proactively identify operational risks and mitigation strategies.
- Build strong working relationships with internal teams and external clients, communicating responsibilities, expectations, and technical information clearly and respectfully to ensure GMP readiness and provide technical support throughout production campaigns.
- Identify opportunities for process optimization and efficiency improvements across platform manufacturing processes and contribute to discussions on continuous improvement.
- Bachelor’s degree in a…
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