ABOUT FORGE

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 idea 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.

PHYSICAL REQUIREMENTS:

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 such as cleanroom gowning. 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.
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.
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.

ABOUT THE ROLE

The Lead, GMP Manufacturing Support plays a critical role in maintaining and supporting GMP-compliant cleanroom environments (ISO 5–8 / Grade A–D) essential for the production of viral vector products. This role is responsible for overseeing contamination control strategies, coordinating day-to-day operations, and leading a team of personnel responsible for cleaning and GMP support activities. The ideal candidate brings a strong understanding of aseptic practices, contamination control, and GMP regulations, along with the leadership skills to promote a high standard of compliance, safety, and operational excellence.

WHAT YOU’LL DO:

• Lead the cleanroom cleaning team to perform routine and non-routine cleaning operations per SOPs and GMP requirements.
• Oversee cleaning of aseptic fill areas, upstream/downstream suites, airlocks, corridors, and equipment in accordance with validated procedures.
• Perform verification of cleaning and sanitization activities and ensure accurate documentation; perform the manufacturing review of logbooks and associated documents; and resolve out-of-trend situations promptly.
• Act as SME for cleanroom behaviors, gowning, and contamination control best practices.
• Support deviation investigations, root cause analysis, and CAPA development related to cleaning issues or contamination events.
• Plan and assign daily tasks for effective resource utilization, collaborating with planning, and maintaining schedules.
• Train and coach new and existing staff on cleaning techniques, gowning, aseptic behavior, and cleanroom discipline.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Environmental Monitoring, and Facilities & Engineering to resolve issues and drive continuous improvement.
• Support cleaning validation and requalification activities for classified spaces and equipment.
• Manage cleanroom inventory to ensure availability of common-use items and uninterrupted operations.
• Oversee consumable expiration tracking and storage, implementing rotation protocols and guiding technicians to meet operational and regulatory standards.
• Other responsibilities may include supporting tubing sets preparation, process improvement initiatives and collaborating with cross-functional teams to ensure the efficient production of gene therapy products.
• May assist with preparing for regulatory inspections (FDA, EMA) as the subject matter expert for contamination control practices.