Upstream Process Development Director - Viral Vectors

Forge Biologics; Columbus (OH); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Health insurance

401(k) with company match

Paid parental leave

Annual bonus opportunities

Onsite fitness facility

Mentorship and professional growth

Comprehensive benefits package

Job summary

Forge Biologics is seeking an Associate Director of Upstream Process Development to lead viral vector production programs, design scalable upstream processes, and drive technology transfer to GMP manufacturing. You will manage a team of scientists and collaborate across MS&T, QC, and manufacturing to ensure robust, compliant processes.

The role combines technical excellence with leadership, regulatory awareness, and a commitment to delivering high-impact gene therapy manufacturing improvements

Qualifications

• Experience leading upstream process development for viral vector production.
• Ability to design, execute, and optimize scalable upstream processes.
• Experience with technology transfer to GMP manufacturing and regulatory alignment.

Responsibilities

• Lead day-to-day operations of upstream process development for viral vector production (AAV and LV).
• Senior-level technical expert responsible for complex development initiatives.
• Manage multiple programs to a high degree of quality with scientific rigor and regulatory alignment.
• Mentor and coach scientists and associates, building capabilities and a culture of quality and safety.
• Set technical strategy and drive process design improvements in collaboration with MS&T, QC, and GMP teams.
• Author CMC documents and support regulatory filings in cross-functional teams.
• Influence team culture through leadership and clear communication.
• Partner with Downstream, Analytical, and Manufacturing teams for successful tech transfer.
• Oversee development of scalable upstream processes within timelines and budget.
• Serve as SME for upstream operations and troubleshooting.

Skills

Mammalian culture

Transfection

Viral production

DOE methods

Statistics

Leadership

Communication

Project management

Mentorship

Education

Bachelor’s degree in Chemical Engineering, Biology, Bioengineering, or related field

Master’s or Ph.D. in Chemical Engineering, Biology, Bioengineering, or related field

Job description

Forge Biologics is seeking an Associate Director of Upstream Process Development to lead viral vector production programs, design scalable upstream processes, and drive technology transfer to GMP manufacturing. You will manage a team of scientists and collaborate across MS&T, QC, and manufacturing to ensure robust, compliant processes.

The role combines technical excellence with leadership, regulatory awareness, and a commitment to delivering high-impact gene therapy manufacturing improvements