Sr. Scientist Drug Product Fill Finish

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.

Our lead programs are focused on the treatment of metabolic diseases such as diabetes (Type 1 and 2) and severe obesity. We are looking for a Drug Product Development Group Leader to join our team. This position requires a highly self-motivated and flexible individual who operates well in a start-up environment.

ESSENTIAL FUNCTIONS:

• Provides technical leadership to drug product development project teams within area of expertise and commits resources to execute specific project tasks
• Develops project strategy and communicates complex data/decisions within department and cross functionally.
• Establish Drug Product/Fill-Finish criteria to maximize stability and quality attributes for all AAV products
• Contributes significantly and independently to drug product formulation development work
• Independently perform experiments to minimize product loss and ensure cryo-stability of final drug product
• Coordinates others in creating technical reports including reviewing and editing.
• Conducts analysis of technical and conceptual risk and trends.
• Identifies process trends and defines/champions process strategy or use of novel technologies.
• Employ state of the art analytical techniques to ensure product quality
• Acting liaison between clinical development and process development to ensure formulations do not interfere with drug efficacy while maintaining stability
• Author documents in support of manufacturing activities
• Manage activities, equipment, inventory and projects of the process development lab
• Collaborate with other scientists and routinely present data
• Perform other duties as necessary

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 with various HPLC platforms and software
• Experience with QBD principles
• Experience with ddPCR and qPCR techniques
• Knowledge of current AAV quantitative and qualitative tools
• State of the industry analytic knowledge
• Ability to identify excipients, additives, and process impurities using various techniques.
• Knowledge of degradation pathways and characterization for biologic products
• Experience in working in a multi-disciplinary team environment.
• Previous experience contributing to regulatory filings.