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GMP Manufacturing Technician I

2 months ago

Columbus, Ohio, United States Forge Biologics Full time
Job Overview

About Forge Biologics

Forge Biologics, a prominent entity within Ajinomoto Bio-Pharma Services, is dedicated to advancing gene therapy development. Our mission is to facilitate access to transformative gene therapies, turning innovative ideas into tangible solutions. We collaborate with a diverse range of stakeholders in the gene therapy sector, including researchers, healthcare professionals, biotechnology firms, and patient advocacy groups. Our commitment is unwavering: to prioritize patient needs and expedite the delivery of groundbreaking therapies to those in need.

Located in a state-of-the-art facility, Forge Biologics operates a custom-designed cGMP environment tailored for AAV manufacturing, providing comprehensive manufacturing services.

Team Overview

The GMP Manufacturing team is tasked with producing AAV Gene Therapy products, adhering strictly to the highest Good Manufacturing Practices (GMPs). This dedicated group ensures the creation of safe and effective gene therapy solutions.

Position Summary

We are in search of a meticulous and driven individual to join our GMP Manufacturing, Upstream team. As a Technician I in GMP Manufacturing - Upstream, you will be integral to the production and cultivation of AAV-based gene therapy products, ensuring compliance with current Good Manufacturing Practices (cGMP) regulations. This role presents a unique opportunity to contribute to the advancement of innovative therapies that have the potential to significantly impact patient lives.

Key Responsibilities

  • Carry out upstream manufacturing tasks in accordance with established Standard Operating Procedures (SOPs) and batch records.
  • Set up and manage bioreactors, centrifuges, filtration systems, and other essential equipment for upstream processing.
  • Prepare media and buffers, and perform aseptic transfers of materials while adhering to cGMP standards.
  • Monitor critical process parameters during production and report any deviations or irregularities.
  • Conduct sampling and in-process testing to maintain optimal culture conditions and product integrity.
  • Accurately document all manufacturing activities, data, and results in compliance with cGMP regulations.
  • Work collaboratively with cross-functional teams to investigate and resolve deviations, non-conformances, and quality issues.
  • Engage in process improvement initiatives and assist in the implementation of new technologies, equipment, and methodologies.
  • Adhere to safety protocols and environmental health and safety guidelines.
  • Participate in training programs and stay informed about current industry developments.

Qualifications

  • Demonstrated technical aptitude and experience in applying scientific principles.
  • Exceptional organizational skills with the ability to manage multiple tasks in a dynamic environment.
  • Strong attention to detail and the capability to follow written procedures precisely.
  • Effective interpersonal and communication skills for collaboration with team members.
  • Dedication to adhering to SOPs, safety protocols, and regulatory standards.
  • Ability to adapt to shifting priorities and work independently as well as collaboratively.
  • Willingness to work in shifts as dictated by manufacturing requirements.

Preferred Qualifications

  • Familiarity with cell culture techniques, bioreactors, centrifuges, and filtration systems.
  • Basic knowledge of viral vector-based gene therapy processes and associated quality standards.

Work Environment & Physical Requirements

This role involves working in both laboratory and standard office settings. The employee will be required to remain stationary for extended periods and must regularly utilize personal protective equipment. The ability to work in confined spaces and discern small details is essential.

This job description outlines the responsibilities and qualifications necessary for the position. Duties and responsibilities may evolve as needed.

Forge Biologics is an equal opportunity employer committed to fostering an inclusive and diverse workforce.

We offer a comprehensive benefits package designed to support the well-being and satisfaction of our employees.