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.
The Senior Engineer, Process Development will be responsible for driving 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.
- Drive 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
- Establish detailed experimental plans and deliver robust data packages
- 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
- Ph.D. in Biological Engineering, Chemical Engineering, or related discipline with 2+ years of relevant industry experience in a drug development setting
- Experience in upstream and downstream process development for DNA and/or vector production
- Experience with DNA and/or vector purification technologies
- Experience with scale-up for GMP manufacturing and associated documentation for regulatory filings preferred
- Previous use of DOE methods in development preferred
- Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions
- Works well in fast-paced startup environment