Associate Director, PD Upstream
Forge Biologics
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Benefits offered by this job
Job summary
Forge Biologics is seeking an Associate Director to lead upstream process development for viral vector production (AAV/LV). You will manage a team of scientists and associates, design experiments, and scale processes for GMP transfer.
Combining technical excellence with leadership, you will drive regulatory readiness, collaborate with MS&T, QC, and Manufacturing, and author critical CMC documents to support global programs.
Qualifications
- Bachelor's degree in Chemical Engineering, Biology, or a related field.
- Proven mammalian suspension cell culture and viral production experience.
- Strong DOE and statistical analysis skills.
- Excellent communication, leadership, and collaboration.
- Experience with technology transfer to GMP manufacturing.
- Experience mentoring junior team members.
Responsibilities
- Lead day-to-day upstream process development operations.
- Manage and mentor scientists and associates.
- Set technical strategy and regulatory alignment with MS&T, QC, and GMP teams.
- Lead cross-functional global program teams and drive tech transfer.
- Authors CMC documents and supports regulatory filings.
- Provide SME guidance on troubleshooting and optimization.
Skills
Education
Tools
Job description
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 ofH.O.P.E.We arehardworking, showing up each day with determination and grit. We areopen, creating a space where ideas flow freely, and every voice is valued. We arepurpose-driven, with every task directly tied to changing lives. And we areengaged, 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.
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.
- 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 p rovides 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
- Partner s 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
- 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
- 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 senio r 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.
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.
Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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, dental and vision insurance start your first day - with 90% of premiums covered for youandyour family.
- 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.
- 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.
- 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.
- A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
- Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
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