Evaluate and understand the properties of new rAAV and propose formulations with sufficient stability during storage and suitability for clinical use.
Conduct in-use stability and delivery device compatibility studies to ensure the quality of drug products during administration at clinical sites.
Author regulatory documents such as IND and briefing documents for meetings with healthcare agencies.; prepare responses to Information Requests from agencies.
For preparing PPQ of drug product manufacturing process and BLA, organize necessary activities, plan studies and obtain sufficient data.
Evaluate new medical devices or container-closures for local injection products
Lead the technical discussion cross-functional/divisional to align and enable efficient drug development work
Evaluate and understand analytical tools and methods to develop rAAV formulation appropriately
Participate the program meetings to achieve key milestones in a timely manner
Regularly present data and conclusions in sub-team meetings
Occasionally presents technology summaries to management and program teams
Qualifications
Advanced degree in biology or engineering with 8+ years of relevant experience in the biopharmaceutical industry
Experience in formulation development for biopharmaceutical products
Experience in authoring IND, BLA or other related regulatory filings, and responding to agency feedback/inquiries
Proven and successful history of taking direction and working independently in a fast-paced environment
Positive, professional attitude with a passion for science
Outstanding collaboration and problem-solving skills; team player with excellent communication and organizational abilities
