Scientist I, QC Analytical

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:   

The Scientist I, Quality Control (Analytical) role will primarily focus on analytical method execution, method qualification, method validation, and troubleshooting efforts. This position will be responsible for executing in-process, final product, and stability testing for AAV vectors, plasmids, and microbial and mammalian cell banks, while ensuring that activities occur in an efficient and cGMP compliant manner. This role will function as a subject matter expert (SME) for either nucleic acid-based methods (e.g. ddPCR, qPCR), protein-based assays (e.g. CE, AUC), or cell-based assays (e.g. TCID50, potency). This position will also be responsible for fostering innovation within the QC department, either independently or by partnering with Analytical Development, ensuring cutting edge technologies are employed to maintain the highest QC standards in the analysis of gene therapy products. This role provides an opportunity to play a significant impact in the success of client gene therapy programs. 

 

Responsibilities: 

• Perform in-process, release, and stability testing for assays relevant to viral vector/gene therapy products, plasmids, and cell banks, including in-process testing, lot release testing, assay qualification, and validations. 

• Function as an SME for either nucleic acid-based methods (e.g. ddPCR, qPCR), protein-based assays (e.g. CE, AUC), or cell-based assays (e.g. TCID50, potency).  Additionally, perform advanced analytical testing quality control assays, including compendial testing, ELISA, and viability assays, to assess the quality, potency, and safety of AAV vector products.  

•  Support troubleshooting of processes/assays as an SME. Represent QC as a SME during audits and inspections.  

• Ensure effective qualifications, validations, and transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.  

• Contribute to authoring and/or reviewing QC documentation, including but not limited to: SOPs,