Analyst I, Quality Control (Environmental Monitoring)

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 (Environmental Monitoring) to join the Forge Biologics team. The Environmental Monitoring Team 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 to contribute to and lead efforts in the execution of manufacturing life changing gene therapies for human use. The candidate will participate in EM sampling, testing and provide hands-on support for new technologies and systems in our GMP manufacturing facility. The ideal candidate will be skilled in EM technical problem-solving to support our growth in the Gene Therapy sector.

Job Duties/Responsibilities:

• Perform EM sampling that incorporates application of GMP principles and methodologies.
• Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing 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).
• Prepare EM data forms, EM labels and execute the EM testing.
• Participate in Media Fill/Process Sims qualifications

Requirements:

• Minimum of a High School Diploma or GED equivalent required.
• Bachelor's Degree in microbiology, biology or related scientific field preferred. (or equivalent work experience).
• 1-2 years’ experience in a GMP or QC environment strongly preferred.
• Must be self-motivating, organized, and proactive.
• Strong technical aptitude, including demonstrated experience in applying scientific reasoning to solve complex problems.
• Ability to work hours necessary to support QC and production
• Job activities require long periods of standing and use of controlled movements as well as aseptic techniques/behaviors in the sterile filling suites.
• Knowledge of aseptic technique preferred.
• Ability to work in confined spaces and near operating equipment.
• Ability to work in loud noise environments and in Personal Protective Equipment (PPE) and Clean Room sterile gowning attire as needed.
• Ability to work independently with minimal supervision.
• 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.

Special Knowledge or Skills Preferred:

• Detailed/Demonstrated knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Knowledge of aseptic technique preferred and attention to detail required.
• Conduct environmental monitoring activities including air, surface and personnel inside the sterile manufacturing areas
• Working knowledge of MS-Office software and PC Skills Required.