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
- Experience managing senior team members
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.
Work Environment and Physical Demands This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment. Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.
We’ve Got You Covered: At Forge Biologics, we believe our people deserve to be taken care of - in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:
Health from day one- Health, dental and vision insurance start your first day - with 90% of premiums covered for you and your family.
Time to recharge- A competitive paid time off plan - because rest fuels innovation.
- 12 weeks of fully paid parental leave so you can focus on family when it matters most.
Rewarding your impact- Annual bonus opportunities for all full-time team members.
- 401(k) with company match to help you plan for the future.
- Special employee discounts, including childcare and dependent care savings.
Your wellness, supported- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage to protect your peace of mind.
Fuel for your workday- A fully stocked kitchen with free snacks and beverages - we keep you energized and ready for what's next.
Grow with us- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
