Manager, Quality Control (QC), Microbiology (Micro) and Environmental Monitoring (EM)

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  

We are currently seeking a Manager, Quality Control (QC), Microbiology (Micro) and Environmental Monitoring (EM) to join the Forge Biologics team.  The Manager, QC, Micro/EM is responsible for overseeing the daily operations of the QC, Micro/EM Department including environmental monitoring testing programs and in-process and product release testing, to ensure compliance with cGMP standards.

 

What You'll Do:

• Manages the overall operations in the QC Micro Lab, assuring regulatory compliance including State, Federal, and Corporate compliance.
• Responsible for micro testing of raw materials, in-process materials, finished product, and various environment/utility tests.
• Manages EM Program (EM sampling and testing) and EM Analysts.
• Oversees data generated by the QC, Micro/EM team and ensures timely completion of trending reports per required frequency.
• Oversees drafting and execution of EM protocols and studies, gown qualifications and personnel monitoring. (e.g., EMPQ, gown studies, etc.).
• Supports isolator qualifications and biological indicators management.
• Leads corrective action/preventive action (CAPA) for QC, Micro/EM quality events, and reviews corrective actions and assesses implementation of action.
• Develops, implements, and monitors QC, Micro/EM methods and documents (e.g., SOPs, Work Instructions, etc.).
• Assesses and implements continuous improvement of lab efficiency and the EM program.
• Represents the QC Micro/EM function for all external quality and regulatory audits.
• Responsible for GMP compliance, manufacturing quality, laboratory support, and quality planning.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback.
• Ensures all documentation is in accordance with GMP and all reported results are accurate.
• Ensures that suitable written records and work undertaken are kept in accord with cGMP and company procedures.
• Complies with U.S. Food and Drug Administration (FDA) regulations, EU GMP and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Other duties as requested by Quality leadership to support effective laboratory operations and performance metrics.

 

What You'll Bring:

• Bachelor’s Degree in Biology, Microbiology, or related discipline
• 2-3 years of direct supervisory or management experience
• Experience leading micro/environmental monitoring efforts in a Pharma, Biotech, or regulated/GxP industry
• Good aseptic technique is essential for this position
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Ability to present to and interact with Senior Management and Leadership teams

Preferred Skills

• Experience working with contract labs, including contract management, operational oversight, and business process integrations
• Experience with electronic Quality Management Systems (EQMS), Laboratory