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Engineer 1, Material Generation Supervisor

Boston, MA
Overview
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 transform gene therapies, providing cures for unmet medical needs and at a cost enabling global accessibility. In order to efficiently deliver c3DNA to target cells in vivo, Intergalactic is developing innovative delivery platforms using multiple proprietary technologies. This role will actively contribute to process design, development, and optimization for our novel c3DNA manufacturing process.
 
As a company focused on innovative and accessible solutions for patients, Intergalactic is seeking to hire diverse candidates that bring creativity and new perspectives to our Process Development team.  Strong candidates with any background are encouraged to apply.

Responsibilities
  • Establish and lead operations to produce c3DNA for preclinical in vivo studies across all portfolio programs.
  • Organize production timelines and inventory management strategy.
  • Write and maintain detailed protocols for executed processes; collaborate with Process and Analytical Development teams to incorporate process improvements real-time into executed protocols.
  • Work closely with Process and Analytical Development teams to actively drive the design, development, and optimization of Intergalactic's novel c3DNA manufacturing process in order to deliver high purity product at high yields for gene therapy applications.
  • Collaborate with Research, Process and Analytical Development, In Vivo Pharmacology, Engineering and Manufacturing colleagues across Intergalactic to advance c3DNA platform and pipeline.
  • Initiate and drive quality and documentation improvements for c3DNA production process (i.e. incorporating new process controls, etc.).
  • Author technical reports, product generation summaries to support in vivo study documentation, and inventory and supplier strategy assessments as needed.
  • Support Process and Analytical Development studies through material generation and technical design input.
  • Direct manage one material generation lead; role intended to grow into team management over time as group expands.

Candidate qualifications
  • B.S. in Biological Engineering, Molecular Biology, Chemical Engineering, or other related disciplines with 3-5+ years of relevant industry experience in a drug development setting. Associate’s degrees or alternate degrees with relevant experience are also encouraged to apply.
  • Experience interfacing with or executing within a late-stage or GMP manufacturing setting, and/or highly organized and quality-oriented mindset 
  • Experience with quality and documentation requirements for GMP-caliber production
  • Proven collaborator and team player
  • Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions
  • Intellectually curious; eager to brainstorm and test potential answers to tough technical questions
  • Works well in a fast-paced startup environment
  • Eager to bring proven lab-based leadership qualities to a growth-oriented direct management position
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