QC Scientist II: Lead & Develop AAV Analytics

Forge Biologics; Columbus (OH); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Onsite fitness facility

Mental health counseling

Job summary

Forge Biologics seeks a Scientist II, Quality Control, to lead hands-on analytical testing and oversight of QC staff at our Columbus facility. You will ensure testing adheres to cGMP, regulatory requirements, and SOPs while advancing method development and troubleshooting.

You will oversee method transfer, data analysis, and documentation, contributing to continuous improvement and regulatory readiness across pre-clinical to commercial programs.

Qualifications

• Bachelor's (or international equivalent) and/or 6+ years of relevant experience in a scientific field.
• Advanced knowledge of complex molecular biology, biochemistry, or cell biology techniques and analytical methods (e.g., qPCR, ELISA).
• Demonstrated leadership ability and experience managing direct reports.
• Proven ability to execute, troubleshoot, and optimize analytical assays.
• Strong analytical and data interpretation skills.
• Robust understanding of cGMP requirements as they pertain to Quality Control and Analytical Development testing.
• Experience with electronic Quality Management Systems (EQMS), Laboratory Information Management Systems (LIMS), etc.
• SME in at least one: Cell, Protein, or Nucleic Acid assays.
• Able to multitask and communicate effectively.
• Experience with software programs: Microsoft, Veeva, ADP.

Responsibilities

• Perform in-process, release, and stability testing for AAV-based therapeutic candidates from PD, research, and GMP labs.
• Lead and perform advanced QC assays (qPCR, ELISA, SDS-PAGE, Western blot, HPLC) to assess quality, potency, and safety of vector products.
• Support internal process transfer activities and serve as SME to troubleshoot processes/assays.
• Ensure effective transfer of analytical methods to QC across pre-clinical, clinical, and commercial activities.
• Contribute to authoring/reviewing QC reports, SOPs, QC protocols, and comparability reports.
• Conduct root-cause determinations for OOS investigations and implement CAPAs promptly.
• Provide support for Deviations, Change Controls, and CAPAs in testing.
• Review and approve GMP documentation for in-process and final product testing.
• Drive development, optimization, and validation of novel analytical methods.
• Compile data, generate reports, and archive assay data; interpret results.
• Draft/revise process documents and sampling plans.
• Support regulatory/client inspections and internal audits as SME.

Skills

Leadership

qPCR

ELISA

Molecular biology

Biochemistry

Data analysis

Communication

Education

Bachelor's degree or higher in relevant field

Master's or PhD preferred

Tools

LIMS

EQMS

GMP

qPCR instruments

SDS-PAGE

HPLC

Western blot

Job description

Forge Biologics seeks a Scientist II, Quality Control, to lead hands-on analytical testing and oversight of QC staff at our Columbus facility. You will ensure testing adheres to cGMP, regulatory requirements, and SOPs while advancing method development and troubleshooting.

You will oversee method transfer, data analysis, and documentation, contributing to continuous improvement and regulatory readiness across pre-clinical to commercial programs.