Associate Director, PD Upstream

Forge Biologics; Columbus (OH); Vor Ort; USD 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Health insurance

401(k) with company match

Paid parental leave

Annual bonus opportunities

Onsite fitness facility

Mentorship and professional growth

Comprehensive benefits package

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Mammalian culture

Transfection

Viral production

DOE methods

Statistics

Leadership

Communication

Project management

Mentorship

Ausbildung

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

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

Jobbeschreibung

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
• 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.

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.

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.