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Forge Biologics

End-to-end manufacturing of AAV gene therapies

GMP Technician 1 - Downstream

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeColumbus, OH, USAIn-person

About the Job

Requirements

  • A Bachelor's degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering, or a related life science field, or equivalent experience.
  • Strong technical aptitude, including demonstrated experience applying scientific reasoning to solve complex problems.
  • Organizational skills and the ability to multitask in a fast-paced environment while adhering to strict timelines.
  • Interpersonal and written and verbal communication skills to collaborate effectively with team members and stakeholders.
  • Commitment to following standard operating procedures, safety protocols, and regulatory guidelines to ensure compliance and product quality.
  • Ability to adapt to changing priorities and work independently as well as part of a team.
  • Flexibility to work shifts, including weekends and holidays, as required by manufacturing schedules.
  • Ability to stand for extended periods and work in a cleanroom while wearing appropriate gowning and personal protective equipment.

Responsibilities

  • Perform routine downstream manufacturing operations, including chromatography, filtration, ultrafiltration/diafiltration, and viral vector formulation, according to standard operating procedures and batch records.
  • Prepare and operate chromatography systems, filtration systems, centrifuges, and tangential flow filtration systems, ensuring they are properly calibrated and maintained.
  • Execute purification processes for adeno-associated virus-based gene therapy products in compliance with current Good Manufacturing Practices and maintain a clean, organized work area.
  • Monitor critical process parameters during manufacturing and promptly report deviations or abnormalities to the supervisor.
  • Perform in-process testing and quality control checks, including pH, conductivity, and pressure measurements, to ensure product quality and compliance with specifications.
  • Assist with process validation and technology transfer activities, collaborating with cross-functional teams to ensure successful execution and timely completion.
  • Follow safety procedures and environmental health and safety guidelines.
  • Participate in training programs and stay current with industry trends, regulatory requirements, and advancements in gene therapy manufacturing processes.

Desired Qualifications

  • Prior experience working in a current Good Manufacturing Practices manufacturing environment.
  • Experience in downstream processing or biologics manufacturing.
  • Familiarity with purification techniques and downstream bioprocessing equipment, including chromatography systems, filtration systems, and tangential flow filtration systems.
  • Basic understanding of viral vector-based gene therapy processes, principles, and quality requirements.

About the Company

Forge Biologics

End-to-end manufacturing of AAV gene therapies

Forge Biologics provides end-to-end development and manufacturing for gene therapies, using its proprietary engine to translate concepts from the lab to GMP production. It focuses on AAV gene therapies and operates from Hearth, a large cGMP facility built for scalable manufacturing. Revenue comes from offering manufacturing services to other companies and researchers, while it also pursues its own gene therapy programs. Its goal is to be a leading, integrated manufacturing partner in the gene therapy field and to advance its own therapies for rare genetic diseases.

Company size
201-500
Company stage
Acquired
Total funding
$250M
Headquarters
Columbus, OH
Founded
2020

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