About Forge  

Forge Biologics, 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 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.  

 

Summary: 

We are currently seeking a Program Manager, Quality Control to join the Forge Biologics team. In this newly created role, the Program Manager will work as part of a cross functional team coordinating Quality Control Analytical Testing activities to support critical internal and client projects.

 

This position will support documentation and testing activities related to analytical method execution, stability programs, method qualification, and method validation for final products and raw materials. This role will also be responsible for fostering interdepartmental relationships, enabling the QC team to execute various projects supporting gene therapy product characterization and release. The QC Program Manager role will have the opportunity to significantly impact the success of client gene therapy programs.

 

Responsibilities:

• Lead project and routine business coordination of QC Analytical Testing activities, ensuring resources, documentation/deliverables, and schedules are in alignment across site efforts
• Work cross-functionally with Program Management, Planning, and Functional Teams including Manufacturing, Facilities & Engineering, Quality Engineering, Quality Management, Technology Services, and Supply Chain/Warehouse.
• Maintain and manage Projects, Quality Events, Analytical Testing Program Initiatives, and the QC documentation dashboard
• Provide progress updates around release and stability testing, communicating risks and opportunities to management
  • Prepare updates for routine Leadership meetings, as required by Quality Management Leadership
• Support QC continuous improvement objectives, SOPs, and associated controlled documents (templates, forms, controlled lists, work instructions, etc.)
• As necessary, provide review and approval of Quality Control deliverables.
  • QC deliverables to include, but not limited to, drafting of all testing documentation (SP, SPC, stability protocols, etc.), completion of routine and stability testing activities, lab investigation closure, and study reports

 

Qualifications:

• Bachelor’s degree in a scientific field or related discipline.
• Project Management/Coordination experience within an FDA/EU regulated pharmaceutical, biotech, or related industry/manufacturing company
• Proficiency in Smartsheet, MS Project, PowerPoint, Word, Excel, Outlook, etc.
• Experience using electronic Quality Management Systems (e.g., Veeva)
• Working knowledge of laboratory systems
• Ability to communicate with respect to technical or project management issues.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

Preferred:

• Familiarity with analytical testing equipment and processes
• Experience in the application of pre-clinical, clinical, and commercial cGMPs
• Cell & Gene Therapy Industry Experience