Responsible for leading and overall coordination of different drug development projects based on sound science and quality risk management.
Developing high quality robust products and processes that are scalable, stable and bioequivalent to the Reference Product.
Reports on project status, communicates any issues, problems or additional information to project team and management along with recommendations of solutions.
The individual in this position must be versatile, able to accommodate the needs of different developmental projects.
Perform effective problems solving, resolution, and implementation of process improvements.
The candidate should be acquainted with current practices and trends within industry to meet compliance and keep up with technology
Strong background in pharmacokinetics and bioequivalence sciences.
Requires understanding of Current Good Manufacturing Practices (cGMPs), Standard Operating Procedures (SOPs), and up to date knowledge on regulatory guidances and systems for drug products.