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

Forge Biologics

Forge Biologics

IT, Quality Assurance
Columbus, OH, USA
Posted on Tuesday, July 9, 2024

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help 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 Team

The Quality Control - Environmental Monitoring/Microbiology Department is responsible for conducting rigorous microbiological testing and environmental monitoring activities to ensure the safety and quality of our gene therapy products. This team focuses on utilizing state-of-the-art techniques to detect and prevent microbial contamination, contributing to the seamless production of AAV vectors while upholding the highest standards of regulatory compliance

About The Role

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 Do

  • 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.
  • Prior experience in a GxP or regulated environment.
  • Experience with microbiological testing such as Gram-stain, Endotoxin, Bioburden, Osmolality, pH, etc.

Work Environment and Physical Demands

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.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge’s core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

  • HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.
  • OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.
  • PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.
  • ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge’s vision, mission and goals.

We’ve Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

  • Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents
  • Unlimited PTO (plus 14 paid company holidays)
  • Annual bonus for all full-time employees
  • Equity-incentive plan
  • 401(K) company match
  • Fully-stocked kitchen with free food/drinks
  • 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care
  • Employee Assistance Program
  • Wellness benefits (financial planning services, mental health counseling, employer paid disability)
  • Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches