Lead GMP Downstream Specialist — Gene Therapy Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Parental leave

Annual bonus opportunities

401(k) with company match

Onsite gym / wellness

Job summary

Forge Biologics seeks a Lead, GMP Manufacturing - Downstream to lead downstream operations for purification of viral-based vectors in a cGMP cleanroom at The Hearth, Columbus. You will manage a team of technicians, optimize processes, and drive tech transfer to GMP while ensuring documentation and client-ready results.

Requirements include 4+ years in downstream GMP manufacturing, expertise in column packing, TFF, and chromatography, and strong problem-solving with cGMP knowledge.

Qualifications

• 4+ years of experience in downstream GMP manufacturing, with BS/MS preferred.
• Experience in column packing, TFF, and affinity/anion exchange chromatography.
• Proficient in purification processes: chromatography, filtration, centrifugation.
• Working knowledge of cGMP requirements in biopharma.
• Self-motivated, organized, and proactive.
• Able to work production hours and in loud PPE environments.

Responsibilities

• Lead downstream operations for purification of viral-based vectors in GMP cleanroom.
• Plan and manage downstream activities, process optimization, and tech transfer to cGMP for viral vectors.
• Demonstrate proficiency with column packing/testing, TFF, and affinity/anion exchange chromatography.
• Complete and review documentation concurrently with manufacturing processes.
• Collaborate with MS&T to support internal process transfer from Process Development to GMP.
• Compile data with minimal oversight to author reports and client-facing summaries.
• Collaborate with QA/QC to satisfy GMP regulations and guidance.
• Train and mentor junior technicians; perform periodic reviews.
• Report unexpected issues by initiating deviations, investigating root cause, and implementing CAPA.
• Partner with Technical Writing to draft, revise GMP documentation.

Skills

Downstream GMP

Column packing

TFF

Affinity chromatography

Anion exchange

Chromatography

Filtration

Centrifugation

cGMP knowledge

Documentation

Problem solving

Leadership

Mentoring

Education

BS or MS in a relevant field

Job description

Forge Biologics seeks a Lead, GMP Manufacturing - Downstream to lead downstream operations for purification of viral-based vectors in a cGMP cleanroom at The Hearth, Columbus. You will manage a team of technicians, optimize processes, and drive tech transfer to GMP while ensuring documentation and client-ready results.

Requirements include 4+ years in downstream GMP manufacturing, expertise in column packing, TFF, and chromatography, and strong problem-solving with cGMP knowledge.