Director, Analytical Development

Who we are:

Intergalactic Therapeutics is a bio-innovation company focused on overcoming the limitations of viral-based gene therapy and developing a best-in-class non-viral alternative. Intergalactic uses synthetic biology and engineered gene circuits to make covalently closed and circular DNA (“C³DNA”) molecules designed to provide a potentially safer and more effective solution for patients.

The role:

Director of Analytical Development will lead a group of scientists responsible for the development, implementation, and qualification of assays internally and in collaboration with CDMO/CROs in support of Intergalactic’s C³DNA Drug Substance and Drug Product manufacturing processes.

Who you are:

You are a talented analytical development leader with deep expertise in development, qualification, and validation of analytical assays and analytical control strategies required for manufacture and release of gene therapy products, particularly nucleic acids. You have experience and track record of leading assay tech transfer and managing analytical method development and implementation at CRO/CDMOs.

Responsibilities:

• Lead a team of scientists to develop, optimize, and qualify robust molecular, biochemical, physicochemical, and cell-based assays for characterization of C³DNA products.
• Lead design, implementation, and oversight of phase-appropriate Analytical Control Strategy related to C³DNA products.
• Provide technical oversight and mentorship to the Intergalactic analytical team.
• Identify and manage external CDMO/CROs to develop and implement analytical methods for the characterization and release of C³DNA
• Lead transfer of assays to CDMO/CROs and lead continued collaboration to enable subsequent success of analytical methods.
• Lead development of high-throughput process analytics.
• Serve as the subject matter expert in cross-functional CMC teams, and actively participate in development, implementation, and execution of analytical assays.

• Work collaboratively with Research, Process Development, Manufacturing, Quality, Clinical, and Regulatory to provide strategic and technical expertise in analytical methods and testing to advance Intergalactic’s C³DNA platform and pipeline

• Author technical reports, protocols, and relevant sections of regulatory filings.

• Work closely with external academic and industry collaborators.
• Work closely with contract organizations for outsourced development activities.
• Other responsibilities may be assigned as needed by the business. 

Requirements:

• PhD degree in Biological Sciences with a minimum of 10 years or MS degree with a minimum of 12 years of relevant industry experience in a drug development or CDMO setting.
• Demonstrated expertise and leadership in analytical development and analytical control strategies in support of nucleic acids, viral vectors, or vaccine cGMP production.
• Experience and track record of successfully developing and implementing biological, molecular, and physicochemical assays using techniques like ddPCR, ELISA, HPLC, potency and Cell Based Bioassays for characterization of gene therapy products.
• Experience in managing method development in CROs and method transfer to external CRO/CDMOs is required.
• Experience with mentoring, coaching, and growing individuals within a team.
• 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.
• Organized, detail-oriented, and a self-starter who continuously seeks innovative solutions.
• Works well in fast-paced startup environment.
• Prior experience of regulatory filings is preferred.

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.