Forge Biologics

Forge Biologics

Scientist I, QC Analytical

Columbus, Ohio

Sponsorship not specifiedDetected 41 days ago
GMPqPCRCRISPRProtein AnalysisMentoring

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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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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).

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.
  • Additionally, perform advanced analytical testing quality control assays, including c ompendial testing, ELISA, and viability assays, to assess the quality, potency, and safety of AAV vector products.
  • Support troubleshoot ing of processes/assay s as an SME. R epresent 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.
  • 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.

Skills

  • Your Future with Us:
  • to enable access to life-changing gene therapies and help bring them from ideas into reality.
  • At Forge, your growth matters.

Company info

  • 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.
  • Here, you won't just watch innovation happen - you'll be part of it.
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This listing is sourced directly from Forge Biologics's careers page and normalized into a canonical job model.