Associate Director, PD Upstream

The role

The Associate Director leads scientific and operational activities for upstream process development for viral vector production. This person manages a team of scientists and research associates to design, execute, and optimize processes for scalability and technology transfer.

What you will do

• Lead day-to-day operations of upstream process development for viral vector production
• Manage multiple programs to ensure technical excellence and regulatory alignment
• Provide mentorship and coaching to scientists and associates
• Set technical strategy and ensure compliance with regulatory expectations
• Author high-impact CMC documents and support regulatory filings
• Partner with Downstream, Analytical, and Manufacturing teams for process integration
• Oversee development of scalable upstream processes within timelines and budgets
• Serve as an SME for upstream operations for troubleshooting and optimization

Required qualifications

• Bachelor’s degree in Chemical Engineering, Biology, Bioengineering, or a related field
• 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
• Ability to work in a laboratory and office environment
• Ability to be stationary for extended periods
• Ability to wear personal protective equipment
• Ability to work in a confined space such as a clean room or laboratory environment
• Ability to identify small details, distinguish colors, and accurately identify objects

Nice to have

• 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
• Experience managing senior team members

Benefits

• Health, dental and vision insurance starting first day with 90% of premiums covered
• Competitive paid time off plan
• 12 weeks of fully paid parental leave
• Annual bonus opportunities
• 401(k) with company match
• Special employee discounts including childcare and dependent care savings
• Onsite fitness facility at The Hearth
• Mental health counseling and financial planning services
• Employer-paid short and long-term disability coverage
• Fully stocked kitchen with free snacks and beverages
• Professional development resources, training, and mentorship programs

About the company

Forge Biologics aims to enable access to life-changing gene therapies. The team works out of The Hearth, a 200,000-square-foot cGMP facility in Columbus, Ohio.