Scientist I, QC Analytical(2nd Shift)

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 .
• Support troubleshoot ing of processes/assay s . R epresent QC during audits and inspections from bench level as needed .
• 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, analytical methods and forms, qualifications protocols, and validation protocols.
• Conducts thorough investigations to determine root cause of OOS investigations and other non-conforming results and implements appropriate corrective and preventative actions in a timely manner.
• Provide support for Deviations, Change Controls, and CAPAs related to in process and final product testing.
• Review and approve GMP documentation associated with in process , final product , and stability testing.
• Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
• Provide technical guidance and mentorship to junior team members, promoting their personal growth and skill development.
• Compile data with minimal oversight, generating reports, and archiving assay data; responsible for performing the analysis and interpretation of assay results.
• Support regulatory and client inspections and internal audits of GMP systems.
• Manage tracking and trending of in process and final product testing data, including, but not limited to; leading/ participating in out of specification (OOS)/out of trend (OOT) Laboratory Investigations.

Requirements

• Bachelor's, Master's, or PhD or in a relevant scientific field (e.g., biology, biochemistry, molecular biology). Advanced degree preferred.
• Experience in either nucleic acid-based methods (e.g. ddPCR, qPCR) or protein-based assays (e.g. CE, AUC) based on experience. Advanc

Additional Information

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. Position Overview: 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 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.

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