Sr. Scientist, Drug Product Development Leader

SUMMARY:

Kriya is a next-generation gene therapy company focused on designing and developing transformative new treatments for highly prevalent and severe chronic diseases. We target conditions where the underlying biology is well-understood, rationally designing one-time gene therapies to durably express therapeutic proteins within the appropriate human tissues.

We are looking for a Drug Product Development Leader to join our team. The ideal candidate will independently design product formulation as well as coordinate stability and forced degradation studies. It is an exciting opportunity to lead in a cross functional team environment. Join us in leading the way in gene therapy research.

ESSENTIAL FUNCTIONS:

• Contributes independently to designing drug product formulation appropriate for program.
• Defines Drug Product process to maximize stability and quality attributes for AAV products
• Coordinates stability studies and forced degradation studies across programs.
• Leads cross functional team between clinical development and process development to ensure program formulations meet desired characteristics
• Authors, reviews and edits technical reports
• Collaborate with other scientists and routinely present data
• Assists Engineering and Manufacturing teams in the qualification of DP operations.

MANDATORY EDUCATION:

• BS or equivalent with 10 years relevant experience, MS degree or equivalent with 8 years relevant experience, PhD or equivalent with 5 years relevant experience

SKILLS AND REQUIREMENTS:

• Experience executing Biologics Formulation Development Workflows
• Experience with QBD principles
• Knowledge of current AAV product characteristics and analytical techniques.
• Understanding of excipients, salts/buffers, and corresponding impact on AAV DP
• Knowledge of degradation pathways and characterization for biologic products
• Experience in working in a multi-disciplinary team environment
• Previous experience contributing to regulatory filings.