Lead process development and optimization for pharmaceuticals, ensuring successful transition from lab to commercial scale. Collaborate with cross-functional teams to drive innovation and enhance product quality.
* Develop products from concept to registration.
* Supervise development staff and maintain GMP status.
* Establish credibility through external presentations and partnerships.
* Deliver process characterization and validation studies.
* Review technical data for regulatory filings.
* Provide technical expertise for troubleshooting.
* Prepare reports and documents for regulatory sections.
* Coach and develop staff, manage resources and budget.
* Risk assess new products and processes.
* Drive customer centricity and project management.
Manage department budget, FTE utilization, and liaison with support groups.
Develop staff, set objectives, and provide feedback.
Devising training and development plans for the group.