Scientist/Sr. Scientist, Upstream Process Development

Job Summary

Homology Medicines seeks an outstanding Scientist, Upstream Process Development, to assist in the development of viral manufacturing processes and scale-up strategies. The individual in this role will be a highly skilled, talented and motivated scientist who will focus on the scale up of cell-based methods for producing AAV vectors. We seek candidates with proven ability to work independently after initial training and collaboratively to achieve optimized project plans, with the goal to deliver products that transform the lives of patients.

Essential Functions and Duties

  • Optimize critical scientific and engineering parameters for AAV production including cell culture, virus harvest, feed strategies, and lysis and clarification
  • Perform vector manufacturing process development and experience with optimization using DOE-based studies
  • Evaluate raw materials and equipment ensuring scalability and compatibility with GMP operations
  • Work collaboratively with development and manufacturing teams to integrate new discoveries and scale-up strategies into production process
  • Participate in the writing and review of standard operating procedures and technical transfer documents
  • Author technical reports, tech transfer documents, IND, CTA, BLA, MAA content and prepare scientific presentations as needed

Skills and Experience

  • BS/MS or equivalent with 6+ years industry experience or PhD with 3+ years industry experience
  • Familiarity with lab-scale and large-scale production platforms including adherent cell systems, bioreactors, and wave bags
  • Expertise in the manufacturing of live virus or viral vector product in a high-volume production environment preferred
  • Previous production of biologic products using transfection-based platforms
  • Experience in the preparation of IND or regulatory documents related to viral products
  • Adept at conducting routine testing and limited troubleshooting of multiple methods
  • Able to effectively manage and prioritize multiple parallel laboratory activities is essential
  • Independently motivated, detail oriented and good problem-solving ability
  • Excellent interpersonal written and oral communication skills

Interested candidates should forward a cover letter and resume/CV to careers@homologymedicines.com.