Analyst I, Quality Control - Environmental Monitoring/Microbiology

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.  

Summary: 

We are currently seeking an Analyst I, Quality Control (QC) - Environmental Monitoring & Microbiology to join the Forge Biologics team. This is an exciting opportunity to join our QC team and to lead and contribute to the production of life-changing gene therapies for human use. This role is responsible for conducting microbiological testing and environmental monitoring (EM) of cleanrooms within our facility, while also providing hands-on support for the implementation of new technologies and systems in our GMP manufacturing facility.

 

What You'll Bring:

• Conduct various microbiological tests in a laboratory setting, including Gram staining, Endotoxin analysis, Bioburden determination, Osmolality measurements, and pH testing.
• Execute environmental monitoring activities by collecting air and surface samples within designated cleanroom areas to ensure compliance with regulatory standards.
• Assist in analyzing Environmental Monitoring data trends using software such as JMP and LIMS to identify potential areas for improvement or compliance issues.
• Participate in thorough investigations to determine the root cause of OOS results and contribute to the implementation of corrective and preventive actions in a timely manner.
• Develop and implement work plans to meet production and scheduling requirements from both internal and external clients, ensuring timely completion of tasks.
• Prepare microbiological equipment, samples, environmental monitoring data forms, and labels for testing, ensuring accuracy and compliance with protocols.
• Collaborate in Media Fill, Process Simulation, and Smoke Studies to evaluate and validate manufacturing processes and equipment performance.

What You'll Bring : 

• Bachelor's Degree in Microbiology, Biology or related scientific field (or equivalent work experience).
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Excellent organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines. 
• Good interpersonal and communication skills, both written and verbal, to effectively collaborate with team members and stakeholders. 
• Ability to adapt to changing priorities and work independently as well as part of a team. 
• Flexibility to work in shifts, including weekends and holidays, as required by manufacturing schedules.

Preferred Skills:

• Knowledge of aseptic technique or behavior.
• Experience in a GxP environment or other regulated industry.
• Prior experience performing microbial testing including but not limited to: Gram-stain, Endotoxin, Bioburden, Osmolality, pH, etc.

 

Physical Requirements:

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.

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