Senior Associate Scientist, MS&T Downstream
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:
As an Associate Scientist II Senior Associate Scientist, MS&T, you will play a key role in developing, optimizing, and supporting gene therapy manufacturing processes within the Manufacturing Science and Technology (MS&T) department. This multidisciplinary role collaborates closely with process development, manufacturing, quality, validation, facilities and engineering, and regulatory teams to ensure upstream, downstream, fill‑finish, buffer preparation, and support‑function processes are scalable, robust, and aligned with regulatory expectations. As a reliable independent contributor, you will execute moderately complex, recurring assignments, adapting established procedures to varied situations and identifying refinements that enhance consistency and performance. You will help identify minor process gaps, support continuous improvement initiatives, and strengthen overall operational reliability, while also training peers on foundational tasks and occasionally influencing adjacent functions. Through this work, you will contribute to day‑to‑day operational excellence, team deadlines, audit readiness, and quality outcomes, playing a meaningful role in the organization’s broader success.
Responsibilities:
- Serve as a technical contributor during technology transfer activities from Process Development or clients into GMP Manufacturing, including defining critical quality attributes, key process parameters, and conditions essential for compliant manufacturing under cGMPs.
- Lead the development, review, and maintenance of key documentation such as manufacturing batch records, production plans, bills of materials and SOPs.
- Perform process monitoring by collecting, analyzing, and summarizing manufacturing data; prepare campaign summary reports and provide insights that strengthen process understanding and operational decision‑making
- Support GMP execution of new processes and act as a Subject Matter Expert (SME) for change controls, deviation investigations, and CAPAs.
- Track progress of routine manufacturing and technology transfer activities, provide timely updates, and proactively identify operational risks and mitigation strategies.
- Build strong working relationships with internal teams and external clients, communicating responsibilities, expectations, and technical information clearly and respectfully to ensure GMP readiness and provide technical support throughout production campaigns.
- Train peers on foundational tasks and demonstrate increasing independence in supporting client programs, addressing production challenges, and advancing process understanding within MS&T.
- Identify and recommend opportunities for process optimization, efficiency improvements, and enhancements to MS&T practices, procedures, and platform manufacturing processes.
Qualifications:
- Bachelor’s degree in a relevant scientific discipline with 3+ years of directly related industry experience
- Behaves ethically and in alignment with organizational values, showing strong communication, organizational, interpersonal, and emerging problem‑solving skills
- Demonstrates growing independence by identifying minor issues or opportunities, proactively seeking feedback, and expressing ideas effectively in both written and verbal formats
- Collaborates effectively by training teammates, completing assigned tasks, and contributing constructively to group discussions
Preferred Skills:
- Experience working with viral vectors (AAV, Lentivirus, etc.) in a GMP setup.
- Proven track record in supporting tech transfers.
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
The work environment is fast paced. This position has the utmost responsibility for comprehending biologics manufacturing compliance with procedures and regulations regarding a safe and collaborative work environment relative to actions and conduct.
This position works in a typical office environment where the physical demand varies depending on the specific tasks and duties assigned. The employee may be stationary (standing/sitting) for extended periods of time. The employee will be made aware and acknowledge established procedures regarding personal protective equipment and safety requirements specific to the company. Must be able to work in office space and trained & qualified to enter a production suite(s) or laboratory environment for general understanding of the business.
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.