Analytical QC Scientist I – Gene Therapy

Forge Biologics; Columbus (OH); On-site; USD 85,000 - 115,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Parental leave

Onsite fitness facility

Mentorship programs

Professional development

Job summary

Forge Biologics in Columbus, OH is seeking a Scientist I, Quality Control (Analytical) to execute in-process, release, and stability testing for AAV vector products, plasmids, and cell banks, ensuring cGMP compliance and high data quality.

You will serve as SME for nucleic acid-, protein-, or cell-based assays (ddPCR/qPCR, CE/AUC, TCID50, potency), drive method development, support audits, mentor junior staff, and collaborate with Analytical Development to advance innovative QC approaches.

Qualifications

• Bachelor's, Master's, or PhD in biology, biochemistry, molecular biology or related field.
• Advanced knowledge of molecular biology techniques and analytical methods.
• Proven ability to execute, troubleshoot, and optimize analytical assays.
• Experience leading, mentoring, and guiding junior team members.
• Strong data interpretation and understanding of cGMP requirements.

Responsibilities

• Perform in-process, release, and stability testing for viral vectors, plasmids, and cell banks.
• Serve as SME for nucleic acid-, protein-, or cell-based assays; perform advanced QC tests.
• Support troubleshooting, audits, and inspections as SME; contribute to CAPAs.
• Qualify, validate, and transfer analytical methods to QC for various programs.
• Author/review QC documents and participate in investigations of OOS/OOT results.

Skills

ddPCR

qPCR

CE

AUC

TCID50

Potency

Nucleic acid methods

Protein assays

Cell-based assays

Education

Bachelor's degree

Master's degree

PhD

Tools

EQMS

LIMS

Job description

Forge Biologics in Columbus, OH is seeking a Scientist I, Quality Control (Analytical) to execute in-process, release, and stability testing for AAV vector products, plasmids, and cell banks, ensuring cGMP compliance and high data quality.

You will serve as SME for nucleic acid-, protein-, or cell-based assays (ddPCR/qPCR, CE/AUC, TCID50, potency), drive method development, support audits, mentor junior staff, and collaborate with Analytical Development to advance innovative QC approaches.