QC Analytical Scientist II — Lead Method Development

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

Benefits offered by this job

Health insurance

Paid parental leave

401(k) with company match

Onsite fitness facility

Job summary

Forge Biologics Inc. in Columbus, OH, is seeking a Scientist II, Quality Control to lead hands-on analytical testing and oversee QC staff. You will advance method development, validation, and troubleshooting for gene therapy products, ensuring testing aligns with cGMP, regulatory requirements, and internal SOPs.

The role emphasizes leadership, mentoring, and collaboration with PD, research, and GMP laboratories to drive quality improvements and support pre-clinical through commercial activities.

Qualifications

• Bachelor’s degree or international equivalent with 6+ years of relevant experience and demonstrated leadership.
• Advanced molecular biology/biochemistry techniques and analytical methods (qPCR, ELISA).
• Proven ability to coach and mentor direct reports.
• Strong data interpretation and quality improvement focus.
• Robust understanding of cGMP in QC and analytical testing.

Responsibilities

• Perform in-process, release, and stability testing for AAV-based products.
• Lead analytical QC assays (qPCR, ELISA, SDS-PAGE, Western blot, HPLC).
• Oversee SME activities to troubleshoot processes and transfer methods.
• Draft and review QC documents and specifications.
• Investigate OOS and CAPA actions with timely corrective actions.
• Support regulatory inspections and internal GMP audits.
• Provide mentorship and performance management for QC staff.

Skills

qPCR

ELISA

SDS-PAGE

Western blot

HPLC

Leadership

Mentoring

Coaching

cGMP knowledge

Data interpretation

Education

Bachelor’s degree

Master’s degree

PhD

Tools

EQMS

LIMS

Veeva

ADP

Job description

Forge Biologics Inc. in Columbus, OH, is seeking a Scientist II, Quality Control to lead hands-on analytical testing and oversee QC staff. You will advance method development, validation, and troubleshooting for gene therapy products, ensuring testing aligns with cGMP, regulatory requirements, and internal SOPs.

The role emphasizes leadership, mentoring, and collaboration with PD, research, and GMP laboratories to drive quality improvements and support pre-clinical through commercial activities.