Associate Director, Formulation Development
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.
Our lead programs are focused across multiple disease areas within a rapidly growing pipeline. We are looking for an Associate Director, Formulation Development to join our team. This position requires a highly self-motivated and flexible individual who operates well in a start-up environment.
• Designs preformulation, formulation, forced degradation, material compatibility and In Use Stability studies appropriate for each program
• Coordinates and contributes to the laboratory activities including samples preparation and analysis
• Coordinates non-GMP stability studies across programs.
• Leads cross functional team between manufacturing sciences, clinical development and analytical development to ensure final drug product meet desired characteristics
• Authors, reviews and edits technical protocols and reports
• Collaborates with Technical Operations to define and execute Fill/Finish studies as required
• BS or equivalent with 12 years relevant experience, MS degree or equivalent with 10 years relevant experience, PhD or equivalent with 6 years relevant experience
SKILLS AND REQUIREMENTS:
• Experience executing liquid protein preformulation studies including DOE principles
• Knowledge of current AAV product characteristics and analytical techniques
• Understanding of excipients, salts/buffers, and corresponding impact on biologic formulations
• Understanding of current analytical methods deployed for AAV or protein stability and characterization
• Knowledge of degradation pathways and characterization for AAV or protein products
• Experience in working in a multi-disciplinary team environment
All interested applicants should send a cover letter and resume to: [email protected]