Lead Downstream GMP Manufacturing Engineer

Drive Capital; Columbus (OH); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision

Paid time off

Parental leave

401(k) with match

Onsite fitness facility

Job summary

Forge Biologics in Columbus, OH, seeks a Lead, GMP Manufacturing - Downstream to lead purification of viral vectors in a state-of-the-art cleanroom. You will supervise technicians, drive process optimization, and ensure GMP-compliant documentation and transfer activities for gene therapy programs.

The role requires 4+ years in downstream GMP, strong chromatography and filtration expertise, and the ability to work flex hours in a fast-paced biotech environment.

Qualifications

• 4+ years of downstream GMP manufacturing experience; BS/MS preferred.
• Experience in column packing/testing, TFF, and affinity/anion exchange chromatography.
• Proficiency in purification processes (chromatography, filtration, centrifugation) with ability to operate and troubleshoot equipment.
• Working knowledge of cGMP and biological drug development.
• Self-motivated, organized, and proactive.
• Ability to work hours to support production and product transfer activities.
• Ability to work in loud environments and with PPE.

Responsibilities

• Lead downstream operations for purification of viral-based vectors in a GMP cleanroom.
• Plan and manage downstream activities, process optimization, and technology transfer to cGMP.
• Demonstrate proficiency with downstream equipment (column packing, TFF, chromatography).
• Complete and review manufacturing documentation.
• Collaborate with MS&T for internal process transfers.
• Compile data and author client-facing reports.
• Collaborate with QA/QC to satisfy GMP regulations and guidances.
• Train and mentor junior technicians; perform periodic reviews.
• Report issues, initiate deviations, investigate root cause, and implement CAPA.
• Work with Technical Writing to draft GMP documentation.

Skills

Downstream GMP

Column packing

TFF

Affinity chromatography

Anion exchange

cGMP knowledge

Problem solving

Leadership

Education

BS or MS in related field

Tools

Single-use systems

Chromatography equipment

Job description

Forge Biologics in Columbus, OH, seeks a Lead, GMP Manufacturing - Downstream to lead purification of viral vectors in a state-of-the-art cleanroom. You will supervise technicians, drive process optimization, and ensure GMP-compliant documentation and transfer activities for gene therapy programs.

The role requires 4+ years in downstream GMP, strong chromatography and filtration expertise, and the ability to work flex hours in a fast-paced biotech environment.