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Forge Biologics

End-to-end manufacturing of AAV gene therapies

Associate Director - PD Upstream

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

About the Job

Requirements

  • A bachelor's degree in Chemical Engineering, Biology, Bioengineering, or a related field.
  • Expertise in mammalian suspension cell culture, transfection, and viral production at bench and pilot scales.
  • Understanding of Design of Experiments methodology and statistical data analysis.
  • Prior experience supporting technology transfer to GMP manufacturing.
  • Experience managing junior team members.
  • Prior project management experience.
  • A master's or Ph.D. in Chemical Engineering, Biology, Bioengineering, or a related field is preferred.
  • Experience with recombinant adeno-associated virus or lentiviral production platforms is preferred.
  • Familiarity with current Good Manufacturing Practice principles and regulatory expectations for biologics is preferred.
  • Experience managing senior team members is preferred.

Responsibilities

  • Lead day-to-day upstream process development operations, including experimental design, execution, and data interpretation for viral vector production using adeno-associated virus and lentiviral vectors.
  • Serve as a senior-level technical expert and upstream leader for complex development initiatives.
  • Independently manage multiple programs or initiatives to a high level of quality, ensuring technical excellence, scientific rigor, and regulatory alignment.
  • Manage, mentor, and coach scientists and associates, developing technical capabilities and reinforcing quality, safety, and continuous learning.
  • Set technical strategy, ensure compliance with regulatory expectations and manufacturing readiness with MS&T, QC, and GMP Manufacturing teams, and drive innovation in upstream process design.
  • Author high-impact chemistry, manufacturing, and controls documents, support regulatory filings, and serve as a cross-functional lead in global program teams.
  • Influence team culture through scientific leadership, collaboration, and clear communication.
  • Partner with Downstream, Analytical, and Manufacturing teams to ensure successful process integration and technology transfer.
  • Oversee development of scalable upstream processes, drive innovation and process improvements aligned with company goals, and meet timelines and budgets while maintaining scientific rigor and data integrity.
  • Serve as a subject matter expert for upstream operations, providing guidance on troubleshooting and optimization.

Desired Qualifications

  • Demonstrated ability to collaborate in a cross-functional, matrixed environment.

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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