Senior/Principal Scientist, Upstream Process Development

Overview

At Intergalactic Therapeutics, you can be the fuel that pushes gene therapy to its limits. Intergalactic Therapeutics is not just a bio-innovation company. We are a team of passionate scientists & professionals developing, delivering, and democratizing a novel non-viral gene therapy. Intergalactic Therapeutics' proprietary synthetic c3DNA construct has the potential to deliver transformative therapeutic intervention for patients with unmet medical needs and at cost-enabling global accessibility.

Responsibilities

• Lead design and optimization of current and next generation production processes to enable Intergalactic's c3DNA pipeline
• Design, execute, and analyze systematic experiments to define the cell-free c3DNA platform process design, leveraging novel molecular biology strategies
• Provide strategic leadership for development of upstream processes internally and in collaboration with CDMO partners
• Leverage molecular biology understanding to develop next generation c3DNA production processes
• Lead development, optimization, and scale up of the upstream process development and technology transfer to CMOs for cGMP manufacturing.
• Provide technical and subject matter expertise in cross-functional teams
• Provide oversight of the pre-clinical c3DNA production
• Ensure delivery of robust, scalable, and cost-effective upstream manufacturing processes
• Lead technology development and innovation projects for continues improvement of the upstream process development for c3DNA manufacturing
• Author and review technical documents, protocols, reports, process control strategy, risk assessments, and CMC regulatory filings
• Build and lead a team of highly talented scientists and engineers
• Provide mentorship and coaching to junior staff to advance project goals and provide career development opportunities
• Collaborate with Research, Analytical Development, Engineering, Manufacturing, Clinical and Regulatory leaders across Intergalactic to advance Intergalactic's c3DNA platform and pipeline
• Work closely with external academic and industry collaborators
• Work closely with contract manufacturers for outsourced development activities
• Publish in peer-reviewed journals and present externally at industry forums and conferences

Requirements

• Ph.D. or equivalent in Biological Engineering, Chemical Engineering, Molecular Biology, Biochemistry or related discipline with 6+ years of relevant industry experience in a drug development setting
• Demonstrated expertise and leadership in process development, molecular biology and associated analytical methods
• Demonstrated experience in process development for nucleic acids, viral vectors and/or protein biologics production
• Experience with process scale-up and familiarity with GMP manufacturing considerations
• Working knowledge of GLP/GMP requirements
• Experience with use of DOE approaches in development setting
• Experience authoring regulatory submissions (IND, IMPD, BLA, MAA) is preferred
• Strong, demonstrated leadership skills, including excellent verbal and written communication skills, experience presenting complex data and strategy to cross-functional teams, a collaborative mindset, and ability to build and maintain a dynamic and innovative team
• Experience with mentoring, coaching, and growing individuals within a team; enthusiasm for balancing an innovative, highly technical role with ensuring career development and opportunity for top-performing scientists and engineers
• Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions
• Ability to collaborate and provide leadership in a global cross-functional environment
• Ability to work well in a fast-paced startup environment
• Track record of publishing patents and scientific articles in peer-reviewed journals

We believe diverse backgrounds lead to innovative thinking that enables effective treatment for millions of patients. Intergalactic is committed to making our organization an inclusive place for all individuals regardless of race, religion, national origin, age, sex and gender identity, sexual orientation, pregnancy status, familial status, disability status, veteran status, genetic information or any other protected class. We are also committed to providing reasonable accommodations to qualified individuals with disabilities. If you are selected to interview, to request an accommodation either as part of the interview process or during your potential employment with Intergalactic, please let your recruiter know and a member of our HR team will reach out to you.

If you feel energized by what you read here, but aren't sure you meet every requirement, please consider applying! Above all, we're looking for the right person with skills and talent to grow the company together all while enriching your professional and scientific experience.