Associate Director, PD Upstream

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking, showing up each day with determination and grit. We are open, creating a space where ideas flow freely, and every voice is valued. We are purpose-driven, with every task directly tied to changing lives. And we are engaged, energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

 

About The Role:   

The Associate Director will play a pivotal role in leading scientific and operational activities to support upstream process development for viral vector production. This position will manage a team of scientists and research associates to design, execute, and optimize upstream processes, ensuring robust scalability and technology transfer into GMP manufacturing. The ideal candidate will combine technical excellence with strong leadership and collaboration skills to drive innovation and efficiency in upstream development. 

 

Responsibilities: 

• Lead day-to-day operations of upstream process development, including experimental design, execution, and data interpretation for viral vector production (AAV and LV) 

• Senior-level technical expert and upstream leader responsible for complex development initiatives 

• Independently manages multiple programs or initiatives to a high degree of quality, ensuring technical excellence, scientific rigor, and regulatory alignment 

• Manages and provides mentorship and coaching to scientists and associates, developing technical capabilities and reinforcing a culture of quality, safety, and continuous learning 

• Sets technical strategy, ensures compliance with regulatory expectations and manufacturing readiness in collaboration with MS&T, QC, and GMP Manufacturing teams, and drives innovation in upstream process design 

• Authors high-impact CMC documents, supports regulatory filings, and serves as a cross-functional lead in global program teams 

• Influences team culture through scientific leadership, collaboration, and clear communication 

• Partners with Downstream, Analytical, and Manufacturing teams to ensure successful process integration and technology transfer 

• Oversee the development of scalable upstream processes, promoting innovation and process improvements aligned with company goals, and staying within timelines and budgets while maintaining scientific rigor and data integrity 

• Serve as an SME for upstream operations, providing guidance on troubleshooting and optimization 

 

Qualifications: 

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

• Proven expertise in mammalian suspension cell culture, transfection, and viral production at bench and pilot scales 

• Strong understanding of DOE methodology and statistical data analysis 

• Excellent communication, organizational, and leadership skills 

• Prior experience supporting technology transfer to GMP manufacturing 

• Experience managing junior team members 

• Prior project management experience 

 

Preferred Skills: 

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

• Experience with rAAV or lentiviral production platforms 

• Familiarity with cGMP principles and regulatory expectations for biologics 

• Demonstrated ability to collaborate in a cross-functional matrixed environment 

• Exper