Lead Technician, GMP Manufacturing - Upstream

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.

About The Role

The Lead, GMP Manufacturing – Upstream will play a pivotal role in the production of high-quality Adeno-Associated Virus (AAV) vectors in compliance with Good Manufacturing Practices (GMP) standards and Master Production Records within Forge’s state-of-the-art cleanroom facility. This position will lead a team of skilled technicians, providing leadership and execution of upstream processes, including bioreactor set up and operation, and culture harvest and clarification, to ensure efficient and scalable AAV vector manufacturing for gene therapy and biopharmaceutical applications.

What You’ll Do

Lead a team of technicians responsible for upstream AAV vector manufacturing processes, bioreactor set up and operation, and culture harvest and clarification.

Ensure strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements throughout the manufacturing process to maintain product quality and compliance.

Effectively allocate resources, such as personnel, equipment, and materials, to meet production schedules and project deadlines.

Review and approve batch records ensuring accuracy and completeness of manufacturing documentation. Revise and maintain accurate SOPs.

Support manufacturing deviations, investigations, corrective and preventive actions and change controls (author or review as needed).

Collaborate with internal teams to facilitate the successful transfer of processes and technologies for AAV vector production.

Provide training, mentorship, and guidance to team members to enhance their technical skills and knowledge of upstream manufacturing techniques.

Provides hands on leadership to technicians within a cleanroom environment.

Work closely with Quality Assurance to conduct in-process and final product quality checks to ensure products meet predetermined specifications.

Performs real time batch records review.

Support efforts to scale up upstream processes for AAV vector production to meet growing client demands.

Maintain accurate and up-to-date manufacturing records, including process deviations, change controls, and equipment maintenance records.

Participate in and lead initiatives to drive continuous improvement in manufacturing processes, equipment, and facility infrastructure and support incorporation of new manufacturing processes.

Coordinate with F&E and Metrology PM schedules to ensure all equipment is calibrated and maintained as required.

What You’ll Bring

Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering or related life science field with 7+ years (Associate’s) or 5+ years (Bachelor’s) of direct experience.

5+ years of experience with upstream technologies related to biologics production in bioreactors.

Working knowledge of large-scale bioreactors (>200L) and use of other upstream processing equipment.

Experience executing and troubleshooting cell culture equipment, such as bioreactors, and processes.

In-depth understanding of Good Manufacturing Practices (GMP) regulations and a demonstrated track record of working in a GMP-compliant environment.

Demonstrated leadership abilities, including experience in mentoring and training junior team member.

Ability to work in a dynamic environment, multi-task, and prioritize work.

Must be self-motivating, organized, and proactive.

Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.

Demonstrated leadership abilities, including experience in mentoring and training junior members, leading the team during production process.

Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

Ability to work in loud noise environments and in Personal Protective Equipment (PPE).

Preferred Skills:

Master’s Degree in Biology, Biochemistry, Biomedical Engineering or related life science field (or equivalent experience).

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.

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.

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 UnFORGEttable.

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