GMP Upstream Process Specialist

3 days ago


Columbus, Ohio, United States Forge Biologics Full time
About the Job

We are seeking an experienced GMP Upstream Process Specialist to join our team at Forge Biologics.

This position will be responsible for leading a team of skilled technicians in the production of high-quality Adeno-Associated Virus (AAV) vectors in compliance with Good Manufacturing Practices (GMP) standards and Master Production Records.

  • Lead a team of technicians responsible for upstream AAV vector manufacturing processes, bioreactor set up and operation, and culture harvest and clarification.
  • Ensure strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements throughout the manufacturing process to maintain product quality and compliance.
  • Effectively allocate resources, such as personnel, equipment, and materials, to meet production schedules and project deadlines.
Job Requirements
  • Bachelor's Degree in Biology, Biochemistry, Biomedical Engineering or related life science field with 7+ years of direct experience.
  • Hands-on experience with upstream technologies related to biologics production in bioreactors.
  • Working knowledge of large-scale bioreactors (>200L) and use of other upstream processing equipment.

Estimated Salary: $100,000 - $140,000 per year.



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