Lead, GMP Manufacturing – Upstream

About Forge  

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.    

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.
• Hands-on 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.
• Ability to work in a dynamic environment, multi-task, and prioritize work.
• Must be self-motivating, organized, and proactive.
• Demonstrated leadership abilities, including ex