Lead, GMP Manufacturing Support (cleaning & Sanitization)

Lead, GMP Manufacturing Support (Cleaning & Sanitization)

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.

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.

What You'll Bring:

• Associate's or Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, Engineering) or equivalent experience.
• Minimum 5 years of experience in a GMP manufacturing environment, preferably in biologics, gene therapy, or sterile manufacturing.
• Demonstrated leadership skills with experience overseeing or mentoring team members.
• Strong understanding of cleanroom classifications, contamination control principles, and GMP regulations.
• Experience working within a Quality Management System (QMS).
• Proven experience overseeing manufacturing support functions (e.g., cleaning and sanitization, tube set building and setup).
• Excellent communication, organization, and problem-solving skills.
• Exceptional computer skills, prior experience with a manufacturing software (e.g., MRP or ERP System), and ability to use data analytics to drive process improvements and results.
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing production schedules.
• Ability to work in classified cleanroom environments (ISO 5–8 / Grade A–D) for extended periods while fully gowned in aseptic/sterile PPE attire.
• Able to lift up to 40 pounds and remain standing or walking for extended periods throughout the shift.

The work environment is fast paced. This position has the utmost responsibility for compliance with rules and regulations regarding a safe and collaborative work environment relative to actions and conduct. Other duties may be assigned in addition to those described that aligns with company objectives.

The 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.

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.

Forge Your Future with Us

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.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly FORGE ttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
• Competitive PTO (plus 14 paid company holidays)
• Annual bonus for all full-time employees
• 401(K) company match
• Fully-stocked kitchen with free food/drinks
• Onsite gym
• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
• Employee Assistance Program
• Wellness benefits (financial planning services, mental health counseling, employer paid disability)
• Professional & Personal development resources