Analyst I, Quality Control (QC) - Environmental Monitoring/Microbiology

Company Overview:

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 200,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as their headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. 

Job Overview:

We are currently seeking an Analyst I, Quality Control (QC) - Environmental Monitoring/Microbiology to join the Forge Biologics team. The Quality Control department works in concert with and assists the manufacturing department and plays a critical role in ensuring environmental control of the aseptic manufacturing facility. This is an exciting opportunity within the QC team to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will perform both a combination of Microbiological testing and Environmental Monitoring (EM) of cleanrooms within the facility. The candidate will provide hands-on support for new technologies and systems in our GMP manufacturing facility.

Responsibilities:

• Perform Microbiological testing in lab environment, including Gram-stain, Endotoxin, Bioburden, Osmolality, pH, etc.
• Conduct environmental monitoring activities including air and surface samples within the classified cleanroom areas.
• Support trending of EM data using software’s eg: JMP and LIMS.
• Support thorough investigations to determine root cause of OOS investigations the implementation of appropriate corrective and preventative actions in a timely manner.
• Train junior staff in laboratory skills and scheduling EM sampling.
• Plan work to meet production and schedule requirements from clients (internal and external).
• Preparation of Microbiological equipment and samples, EM data forms, EM labels and execution of EM testing.
• Participate in Media Fill/Process Sims qualifications/Smoke study.

Requirements:

• Bachelor's Degree in Microbiology, Biology or related scientific field (or equivalent work experience).
• Knowledge of aseptic technique or behavior is preferred.
• Ability to work in Cleanroom gowning attire as needed.
• Specific vision requirements include 20/40 near vision (can be corrected with eyeglasses or contacts) and color vision
• In our commitment to safety of our employees and customers a COVID vaccination is required.