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Senior/Principal Engineer, Process Development

Boston, MA
Intergalactic Therapeutics is a bio-innovation company developing, delivering, and democratizing novel non-viral gene therapies for patients. Intergalactic’s proprietary synthetic c3DNA construct has the potential to deliver transformative therapeutic intervention for unmet medical needs and at a cost enabling global accessibility.

Overview
The Senior/Principal Engineer, Process Development will be responsible for leading end-to-end process design, development, and optimization for our novel manufacturing process. This person will report to Eileen Higham, our Senior Vice President, Head of Technical Operations in the company.
 
Responsibilities
  • Lead all aspects of the design, development, and optimization of our novel manufacturing process in order to deliver high purity product at high yields for gene therapy applications
  • Develop and implement innovative upstream and downstream process solutions
  • Build and lead a team of highly talented process development scientists
  • Collaborate with Research, Analytical Development, Engineering, Manufacturing, Clinical and Regulatory leaders across Intergalactic to advance our platform and pipeline
  • Work closely with external academic and industry collaborators
  • Work closely with contract manufacturers for outsourced development activities
  • Author documents for regulatory submissions
Requirements
  • Ph.D. in Biological Engineering, Chemical Engineering, or related discipline with 8+ years of relevant industry experience in a drug development setting
  • Demonstrated leadership in upstream and downstream process development for DNA and/or vector production
  • Demonstrated experience with DNA and/or vector purification technologies
  • Demonstrated experience with scale-up for GMP manufacturing and associated documentation for regulatory filings
  • Previous use of DOE methods in development strongly preferred
  • Knowledge of molecular biology and analytical methods for assessing DNA and/or vector products preferred
  • Demonstrated experience successfully managing small teams of scientists
  • Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions
  • Works well in fast-paced startup environment
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