Forge Biologics

Scientist II, QC Analytical (2nd Shift)

Columbus, Ohio · Mid

Sponsorship not specifiedDetected 6 days ago

GMPqPCRCRISPRResearchMass SpectrometryProtein AnalysisWestern BlottingLeadershipMentoring

About the role

Scientist II, Quality Control: This role combines hands-on analytical testing with leadership and oversight of QC staff.
This role will also be responsible for advancing method development, validation, and troubleshooting efforts for gene therapy products.

Responsibilities

Perform in process, release, and stability testing for our most advanced AAV-based (viral vector) therapeutic candidates generated from PD, research, and GMP laboratories.
Lead and perform advanced analytical testing quality control assays, including qPCR, ELISA, SDS-PAGE, Western blot, and HPLC, to assess the quality, potency, and safety of AAV vector products.
Supports internal process transfer activities and serves as Subject Matter Expert (SME) to troubleshoot processes/assay.
Ensure the effective transfer of analytical methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical, and commercial activities.
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.
Drive the development, optimization, and validation of novel analytical methods to enhance quality control processes.
Draft and revise process documents, assay methods, and sampling plans.
Support regulatory and client inspections and support internal audits of GMP systems as an SME.
Assist/drive 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.

Company info

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.

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